Home NDC 70677-1213 Diphenhydramine Hydrochloride and Zinc Acetate
Product NDC 70677-1213
11-digit product format 706771213
Labeler code 70677
Product ID 70677-1213_4c21745b-806a-28f7-e063-6394a90a352c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form CREAM
Route TOPICAL
Labeler STRATEGIC SOURCING SERVICES LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-13
Marketing end 2027-02-28
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 20; 1 mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
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 Diphenhydramine Hydrochloride and Zinc Acetate Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g ZINC ACETATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087026 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 70677-1213-1 Diphenhydramine Hydrochloride and Zinc Acetate 1 in 1 CARTON CREAM 1 5 70677-1213-1 Diphenhydramine Hydrochloride and Zinc Acetate 28.4 g in 1 TUBE CREAM 28.4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-1213 DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM [STRATEGIC SOURCING SERVICES LLC] 3 Current NDC, 2 package rows 20231222_ec0c9602-35cc-4bb6-b853-794a8b5bf42e.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 73 of 152 · 3,029 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 70677-1213-1 70677121301 1 TUBE in 1 CARTON (70677-1213-1) / 28.4 g in 1 TUBE 1 tube 2023-12-13 2027-02-28 No No Historical