Home NDC 69848-014-05 Acetaminophen Diphenhydramine HCl
Product NDC 69848-014
Requested package NDC 69848-014-05
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69848-014 69848-014-05 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…
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 64 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tylenol PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Jones Healthcare Group - Packaging Services, Inc 639f4e01-9723-a619-e053-2991aa0a549a 2024-08-27 Warnings Exact identifier application number: M013 Extra Strength Acetaminohpen Adult Rapid Burst Cherry ACETAMINOPHEN Major Pharmaceuticals 9e7543d9-6249-45b5-b67d-c1b439423b9c 2024-08-27 Warnings Exact identifier application number: M013 aspirin ASPIRIN Major Pharmaceuticals 58684138-04d1-44a4-bc52-c5b85d93d7a6 2024-08-23 Warnings Exact identifier application number: M013 Up and Up childrens acetaminophen ACETAMINOPHEN Target Corporation 9c3ba4dd-f51b-46ce-91b8-8b617c7b78da 2024-08-23 Warnings Exact identifier application number: M013 CVS Effervescent Pain Reliever ASPIRIN CVS PHARMACY 0761147f-1337-606e-e063-6394a90abd5d 2024-08-22 Warnings Exact identifier application number: M013 pain reliever ACETAMINOPHEN Walgreen Company 8255900a-2d58-4261-8df7-f28319883570 2024-08-21 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN H E B 86a072a9-c3b8-47f7-8598-d66e3d30e762 2024-08-21 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Kroger Company d965eba0-b268-41b2-8e02-5f6d769a44d7 2024-08-18 Warnings Exact identifier application number: M013 equate pain and fever childrens ACETAMINOPHEN Wal-Mart Stores Inc ea68d735-c677-4280-a3a3-ae3eb5ff7462 2024-08-17 Warnings Exact identifier application number: M013 childrens pain and fever ACETAMINOPHEN CVS Pharmacy fac408f0-ebb6-4c72-88ee-2ba85867859c 2024-08-16 Warnings Exact identifier application number: M013 Regular Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24 2024-08-14 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief - Extra Strength ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 1f926637-a61c-8eb7-e063-6394a90a6502 2024-08-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma 6ec12573-03d6-40c1-9945-d345b401e062 2024-08-12 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company eacee273-abd7-4ea4-bcaa-7f74abcc9feb 2024-08-07 Warnings Exact identifier application number: M013 infants pain and fever ACETAMINOPHEN Kroger Company 7dbe284a-c0d5-4ac4-8445-611610f3c0fb 2024-08-02 Warnings Exact identifier application number: M013 Dollar General Effervescent Pain Reliever ASPIRIN Dolgencorp, Inc 1deab362-a325-3a00-e063-6294a90a9acd 2024-08-01 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN FSA STORE INC. 1cd6a3e6-1376-0b7b-e063-6394a90af3d1 2024-07-30 Warnings Exact identifier application number: M013 pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Publix Super Markets Inc 42d271b7-b45f-4497-8de2-4e05b4bebfa9 2024-07-17 Warnings Exact identifier application number: M013 basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 Warnings Exact identifier application number: M013
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 69848-014-05 69848001405 50 TABLET in 1 BOTTLE (69848-014-05) 50 tablet 2019-07-01 0000-00-00 No No Current