Home NDC 41415-661 Acetaminophen and Diphenhydramine HCL
Product NDC 41415-661
11-digit product format 414150661
Labeler code 41415
Product ID 41415-661_465302f5-b590-5105-e063-6394a90aa9d0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler PUBLIX SUPERMARKETS, INC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-02
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
Active strength 500; 25 mg/1; 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 Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Diphenhydramine HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE 500 mg/1 ACETAMINOPHEN 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8GTS82S83M Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 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 41415-661-05 Acetaminophen and Diphenhydramine HCL 50 in 1 BOTTLE TABLET 50 6 41415-661-10 Acetaminophen and Diphenhydramine HCL 100 in 1 BOTTLE TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41415-661 ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [PUBLIX SUPERMARKETS, INC] 4 Current NDC, 2 package rows 20241212_08f549cf-042a-7bf2-e063-6394a90a83ef.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 1 of 84 · 1,678 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 41415-661-05 41415066105 50 TABLET in 1 BOTTLE (41415-661-05) 50 tablet 2024-08-02 No No Current 41415-661-10 41415066110 100 TABLET in 1 BOTTLE (41415-661-10) 100 tablet 2024-08-02 No No Current