Walgreens Arthritis Pain Relief Cream
Histamine Dihydrochloride
Walgreens Company
Human Otc Drug
NDC 0363-5301Walgreens Arthritis Pain Relief Cream also known as Histamine Dihydrochloride is a human otc drug labeled by 'Walgreens Company'. National Drug Code (NDC) number for Walgreens Arthritis Pain Relief Cream is 0363-5301. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Walgreens Arthritis Pain Relief Cream drug includes Histamine Dihydrochloride - .00025 g/g . The currest status of Walgreens Arthritis Pain Relief Cream drug is Active.
Drug Information:
| Drug NDC: | 0363-5301 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Walgreens Arthritis Pain Relief Cream |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Histamine Dihydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HISTAMINE DIHYDROCHLORIDE - .00025 g/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Walgreens Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1091387
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3POA0Q644U
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0363-5301-40 | 113 g in 1 JAR (0363-5301-40) | 30 Apr, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic
Product Elements:
Walgreens arthritis pain relief cream histamine dihydrochloride histamine dihydrochloride histamine butylene glycol c13-14 isoparaffin chondroitin sulfate (shark) emu oil ethylhexyl stearate glucosamine hydrochloride helianthus annuus flowering top laureth-7 methylisothiazolinone dimethyl sulfone polyacrylamide (1500 mw) potassium sorbate sodium polyacrylate (8000 mw) tetrasodium edetate dihydrate .alpha.-tocopherol acetate trideceth-6 water
Indications and Usage:
Uses for temporary relief of minor aches and pains of muscles and joints assited with arthritis, simple backache, strains & bruises.
Warnings:
Warnings for external use only. do not use on wounds or damaged skin or if you are allergic to ingredients in the product.
When Using:
When using this product avoid contact with eyes. if product gets into eyes,rinse thoroughly with water. do not bandage tightly or use a heating pad.
Dosage and Administration:
For use by adults and children over 12 years of age. apply a thin layer to the pain site and massage until thoroughly absorbed into skin. apply no more than 3 to 4 times daily. children 12 years or younger consult a physician.
Stop Use:
Stop use and ask a doctor if rash appears. condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.
Package Label Principal Display Panel:
Principal display panel -jar walgreens arthritis pain relief ndc 0363-5301-40 histamine dihydrochloride 0.025% arthritis pain relief cream net wt 4oz (113g) 70020481b_walgreens_arthritispainrelief_4oz_wic_760245_m115210.jpg