Home NDC 85063-101 Pain Relieving Cream
Product NDC 85063-101
11-digit product format 850630101
Labeler code 85063
Product ID 85063-101_de7597a0-26c9-4a4b-b2b7-10ded0901117
Type HUMAN OTC DRUG
Nonproprietary name Histamine Dihydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Mediapower, Inc. DBA Dr Newton's And Naturals
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-20
Substance HISTAMINE DIHYDROCHLORIDE
Active strength .05 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pain Relieving Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTAMINE DIHYDROCHLORIDE .05 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3POA0Q644U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1542820 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85063-101-85 Pain Relieving Cream 85 g in 1 BOTTLE, PUMP CREAM 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85063-101 PAIN RELIEVING CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [MEDIAPOWER, INC. DBA DR NEWTON'S AND NATURALS] 1 Current NDC, 1 package rows 20250306_9eeea033-ae87-4d83-85d0-b8fa653a0806.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85063-101-85 85063010185 85 g in 1 BOTTLE, PUMP (85063-101-85) 85 g 2025-02-20 No No Current