Home NDC 69536-370 Dimetapp
Product NDC 69536-370
11-digit product format 695360370
Labeler code 69536
Product ID 69536-370_15d9c0b3-b510-242a-e063-6294a90a3946
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Foundation Consumer Healthcare
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-15
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Dimetapp
Brand name suffix Cough and Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049900 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 69536-370-24 DimetappCough and Allergy 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 2 69536-370-24 DimetappCough and Allergy 4 in 1 CARTON TABLET, CHEWABLE 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69536-370 DIMETAPP COUGH AND ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [FOUNDATION CONSUMER HEALTHCARE] 2 Current NDC, 2 package rows 20240415_15b0f5ff-202a-d19f-e063-6394a90af2b8.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 98 of 178 · 3,551 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 69536-370-24 69536037024 4 BLISTER PACK in 1 CARTON (69536-370-24) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2024-04-15 No No Current