Home NDC 69848-014 Acetaminophen Diphenhydramine HCl
Product NDC 69848-014
11-digit product format 698480014
Labeler code 69848
Product ID 69848-014_4690f59f-4424-6231-e063-6294a90a8ca7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Granules USA, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-01
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 69848-014-05 excluded package package 69848-014-02 excluded package package 69848-014-15
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 ACETAMINOPHEN 500 mg/1
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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 69848-014-02 2020-12-30 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-05 2020-12-30 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-15 2020-12-30 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-02 2020-09-27 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-05 2020-09-27 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-15 2020-09-27 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-02 2020-09-25 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-05 2020-09-25 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-15 2020-09-25 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-02 2020-07-22 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-05 2020-07-22 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming 69848-014-15 2020-07-22 EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69848-014-02 Acetaminophen Diphenhydramine HCl 20 in 1 BOTTLE TABLET 20 7 69848-014-05 Acetaminophen Diphenhydramine HCl 50 in 1 BOTTLE TABLET 50 7 69848-014-15 Acetaminophen Diphenhydramine HCl 150 in 1 BOTTLE TABLET 150 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69848-014 ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [GRANULES USA, INC. ] 6 Current NDC, Legacy NDC, 3 package rows 20241218_8c9f68e3-fedc-6457-e053-2995a90a045a.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 2 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 69848-014-02 69848001402 20 TABLET in 1 BOTTLE (69848-014-02) 20 tablet 2019-07-01 0000-00-00 No No Current 69848-014-05 69848001405 50 TABLET in 1 BOTTLE (69848-014-05) 50 tablet 2019-07-01 0000-00-00 No No Current 69848-014-15 69848001415 150 TABLET in 1 BOTTLE (69848-014-15) 150 tablet 2019-07-01 0000-00-00 No No Current