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
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
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69848-014-05
excluded packagepackage69848-014-02
excluded packagepackage69848-014-15

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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c9f68e3-fedc-6457-e053-2995a90a045aAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
69848-014-022020-12-30EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-12-30EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-12-30EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-27EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-27EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-27EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-09-25EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-09-25EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-09-25EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-022020-07-22EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-052020-07-22EXTRA STRENGTH Pain Relief PM Acetaminophen, USP 500 mg/ Diphenhydramine HCl, USP 25 mg Pain Reliever/ Nighttime Sleep-Aid Non-Habit Forming
69848-014-152020-07-22EXTRA 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

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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.562d7901-44d6-4d9b-be8b-a8d468a22c432026-02-13WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
application number: M013
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
application number: M013
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINSportpharm LLCd3379569-7949-4f78-b634-5d4178b21ea42026-02-06WarningsExact identifier
application number: M013
Buffered AspirinASPIRINCardinal Health 110, LLC. DBA Leadere5f68c1a-21f3-45a1-861f-229a95b3721c2026-02-06WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
application number: M013
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
application number: M013
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
application number: M013
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact identifier
application number: M013

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