diphenhydramine hydrochloride

Product NDC
51662-1674
11-digit product format
516621674
Labeler code
51662
Product ID
51662-1674_4e5741df-24d9-1cab-e063-6294a90a2534
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
diphenhydramine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44217a8c-7656-a0f6-e063-6294a90af2adAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1674-1diphenhydramine hydrochloride1 in 1 PACKETTABLET, FILM COATED13

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 98 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporation0ea61a4c-690a-4349-9952-cc17fb1f06712025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 30ctMENTHOLDollar General Corporation892092cc-5a1c-4309-baf9-a040888d35772025-10-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Menthol 80ctMENTHOLDollar General Corporation773f4ad2-6c91-431f-ad3d-c0e53e7ca9182025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe 45ctMENTHOLDollar General Corporation13c7d3b1-12ac-4931-877c-728d3d89942c2025-10-08WarningsExact identifier
application number: M012
Menthol Drops Dollar General Severe Honey Lemon 45ctMENTHOLDollar General Corporationd0c878f0-a737-4583-9847-834af70e7d6f2025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLR.L. ALBERT & SON, INCdc077c36-c403-4b83-894a-e9922e9288412025-10-08WarningsExact identifier
application number: M012
Cough Drops Freegells Strawberry 30ctMENTHOLRL Albert & Son Inc.2ea760f3-df50-4c46-a43d-d5ed07f421a52025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 200ctMENTHOLRL Albert & Son Inc.3ac08274-08d9-4dab-b09a-6e297948a25a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Honey Lemon 30ctMENTHOLRL Albert & Son Inc.8114e1a2-728d-4489-a494-f28a5e7d9bb32025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 30ctMENTHOLRL Albert & Son Inc.0c2e594a-cdf8-4595-bda6-0ebc19ac38502025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 200ctMENTHOLR.L. ALBERT & SON, INCf62b7f75-3275-46c9-880c-64148d0dce592025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLR.L. ALBERT & SON, INC15917bfb-f660-4a12-bdcc-5b4a96e0e1d02025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLRL Albert & Son Inc.92c54c53-c8bb-4576-abae-715a2f3878bf2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol 80ctMENTHOLRL Albert & Son Inc.c96cc162-5908-4990-9dc1-3ce9128442742025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLR.L. ALBERT & SON, INC6842d766-ade6-40b2-831b-f4feac25c6db2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLRL Albert & Son Inc.9f324ca1-0e2a-47e3-997e-2aaa68a857512025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INC2063a013-aa0b-465d-b04f-cfe2e70d749f2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ctMENTHOLR.L. ALBERT & SON, INCcd81488c-74d8-48d9-9c73-ff662a5cd4cd2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN44217a8c-7656-a0f6-e063-6294a90af2ad3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD44217a8c-7656-a0f6-e063-6294a90af2ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51662-1674-1516621674011 TABLET, FILM COATED in 1 PACKET (51662-1674-1) 2012-01-01NoNoCurrent