FDA.reportPublic FDA data

Arthritis Pain Relief Cream

Product NDC
61577-8120
11-digit product format
615778120
Labeler code
61577
Product ID
61577-8120_523333ee-ecce-bcf7-e063-6394a90aea60
Type
HUMAN OTC DRUG
Nonproprietary name
Histamine Dihydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sombra Cosmetics Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-23
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.00025 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arthritis Pain Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.00025 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3POA0Q644U
Rxcui1091387

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-8120-22025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-32025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-42025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream
61577-8120-92025-01-30C16284748780-12cef2736-635f-d83d-e063-dadaa90ab31fArthritis Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8120-1Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-2Arthritis Pain Relief Cream59 g in 1 JARCREAM591
61577-8120-2Arthritis Pain Relief Cream59 g in 1 JARCREAM591
61577-8120-3Arthritis Pain Relief Cream59 g in 1 TUBECREAM591
61577-8120-4Arthritis Pain Relief Cream119 g in 1 JARCREAM1191
61577-8120-4Arthritis Pain Relief Cream119 g in 1 JARCREAM1191
61577-8120-5Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-8Arthritis Pain Relief Cream1 in 1 CARTONCREAM11
61577-8120-9Arthritis Pain Relief Cream266 g in 1 JARCREAM2661
61577-8120-9Arthritis Pain Relief Cream266 g in 1 JARCREAM2661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8120ARTHRITIS PAIN RELIEF CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]1Current NDC, Legacy NDC, 4 package rows20200414_3d3bdd7a-5ee3-487b-b589-a161c553e0ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091387histamine dihydrochloride 0.025 % Topical CreamPSN523333ee-eccd-bcf7-e063-6394a90aea601
1091387histamine dihydrochloride 0.25 MG/ML Topical CreamSCD523333ee-eccd-bcf7-e063-6394a90aea601
1091387histamine dihydrochloride 0.025 % Topical CreamSY523333ee-eccd-bcf7-e063-6394a90aea601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-8120-1615778120011 JAR in 1 CARTON (61577-8120-1) / 59 g in 1 JAR (61577-8120-2) 1 jar2024-10-23NoNoCurrent
61577-8120-26157781200259 g in 1 JAR (61577-8120-2) 59 g2019-12-100000-00-00NoNoCurrent
61577-8120-36157781200359 g in 1 TUBE (61577-8120-3) 59 g2019-12-100000-00-00NoNoCurrent
61577-8120-461577812004119 g in 1 JAR (61577-8120-4) 119 g2019-12-100000-00-00NoNoCurrent
61577-8120-5615778120051 JAR in 1 CARTON (61577-8120-5) / 119 g in 1 JAR (61577-8120-4) 1 jar2024-10-23NoNoCurrent
61577-8120-8615778120081 JAR in 1 CARTON (61577-8120-8) / 266 g in 1 JAR (61577-8120-9) 1 jar2024-10-23NoNoCurrent
61577-8120-961577812009266 g in 1 JAR (61577-8120-9) 266 g2019-12-100000-00-00NoNoCurrent