Home NDC 82908-357-00 AMINO ACTIVE Topical Analgesic Cream
Product NDC 82908-357
Requested package NDC 82908-357-00
11-digit product format 829080357
Labeler code 82908
Product ID 82908-357_09e37389-88cf-6f4c-e063-6394a90a9861
Type HUMAN OTC DRUG
Nonproprietary name HISTAMINE DIHYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler VIREO SYSTEMS, INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-08
Substance HISTAMINE DIHYDROCHLORIDE
Active strength .25 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 AMINO ACTIVE Topical Analgesic Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTAMINE DIHYDROCHLORIDE .25 mg/mL
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 1091387 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82908-357-00 AMINO ACTIVE Topical Analgesic Cream 81.33 mL in 1 JAR CREAM 81.33 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82908-357 AMINO ACTIVE TOPICAL ANALGESIC CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [VIREO SYSTEMS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231112_591b1e7e-a8c0-4640-a592-4e0f3538a40e.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 Marketing end Sample Exclude flag Status 82908-357-00 82908035700 81.33 mL in 1 JAR (82908-357-00) 81.33 ml 2022-08-08 0000-00-00 No No Current