Home NDC 69842-572-08 ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Product NDC 69842-572
Requested package NDC 69842-572-08
11-digit product format 698420572
Labeler code 69842
Product ID 69842-572_5c2cbbe2-c57d-d623-e063-6394a90a36b4
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS Pharmacy, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-23
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 25; 500 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 ACETAMINOPHEN 500 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69842-572-02 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 1 in 1 CARTON TABLET, FILM COATED 1 5 69842-572-02 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 225 in 1 BOTTLE TABLET, FILM COATED 225 5 69842-572-08 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 24 in 1 BOTTLE TABLET, FILM COATED 24 5 69842-572-08 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 1 in 1 CARTON TABLET, FILM COATED 1 5 69842-572-12 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 1 in 1 CARTON TABLET, FILM COATED 1 5 69842-572-12 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 100 in 1 BOTTLE TABLET, FILM COATED 100 5 69842-572-15 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 1 in 1 CARTON TABLET, FILM COATED 1 5 69842-572-15 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 50 in 1 BOTTLE TABLET, FILM COATED 50 5 69842-572-29 ACETAMINOPHEN, DIPHENHYDRAMINE HCL 150 in 1 BOTTLE TABLET, FILM COATED 150 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-572 ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED [CVS PHARMACY, INC.] 4 Current NDC, Legacy NDC, 9 package rows 20240131_6df9a638-09dd-166f-e053-2991aa0a8dd0.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 83 · 1,657 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 69842-572-08 69842057208 1 BOTTLE in 1 CARTON (69842-572-08) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-07-23 0000-00-00 No No Current