FDA.reportPublic FDA data

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
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
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 Diphenhydramine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69848-014-022020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-12-30C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-27C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-25C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-07-22C16284748780-1ab0e2407-2b8a-f274-e053-dbdaa90a6471EXTRA 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 NDCProductDescriptionFormQuantityStrengthSPL version
69848-014-02Acetaminophen Diphenhydramine HCl20 in 1 BOTTLETABLET207
69848-014-05Acetaminophen Diphenhydramine HCl50 in 1 BOTTLETABLET507
69848-014-15Acetaminophen Diphenhydramine HCl150 in 1 BOTTLETABLET1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-014ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [GRANULES USA, INC. ]6Current NDC, Legacy NDC, 3 package rows20241218_8c9f68e3-fedc-6457-e053-2995a90a045a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8c9f68e3-fedc-6457-e053-2995a90a045a7
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8c9f68e3-fedc-6457-e053-2995a90a045a7
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8c9f68e3-fedc-6457-e053-2995a90a045a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69848-014-026984800140220 TABLET in 1 BOTTLE (69848-014-02) 20 tablet2019-07-010000-00-00NoNoCurrent
69848-014-056984800140550 TABLET in 1 BOTTLE (69848-014-05) 50 tablet2019-07-010000-00-00NoNoCurrent
69848-014-1569848001415150 TABLET in 1 BOTTLE (69848-014-15) 150 tablet2019-07-010000-00-00NoNoCurrent