FDA.reportPublic FDA data

Acetaminophen and Diphenhydramine Hydrochloride

Product NDC
37835-537
11-digit product format
378350537
Labeler code
37835
Product ID
37835-537_38f722c5-1d77-e710-e063-6394a90ac4d2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE
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 and Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 8GTS82S83M
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-537-01Acetaminophen and Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET1002
37835-537-25Acetaminophen and Diphenhydramine Hydrochloride250 in 1 BOTTLETABLET2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-537ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [BI-MART]1Current NDC, 2 package rows20250221_70084eea-1480-4c46-b849-4c779319cb74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN70084eea-1480-4c46-b849-4c779319cb742
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD70084eea-1480-4c46-b849-4c779319cb742
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY70084eea-1480-4c46-b849-4c779319cb742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-537-0137835053701100 TABLET in 1 BOTTLE (37835-537-01) 100 tablet2025-02-01NoNoHistorical
37835-537-2537835053725250 TABLET in 1 BOTTLE (37835-537-25) 250 tablet2025-02-01NoNoHistorical