FDA.reportPublic FDA data

diphenhydramine hydrochloride

Product NDC
76457-002
11-digit product format
764570002
Labeler code
76457
Product ID
76457-002_0b586170-9b5f-74dc-e063-6394a90aa09b
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Simpex Pharma Pvt. Ltd
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-09
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
2026-12-31
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
2026-12-31

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
82771f6a-8b3d-4ffa-8b35-09c2faf3582cAvailable 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
76457-002-00diphenhydramine hydrochloride100 in 1 BOTTLETABLET1005
76457-002-00diphenhydramine hydrochloride1 in 1 CARTONTABLET15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76457-002DIPHENHYDRAMINE HYDROCHLORIDE TABLET [SIMPEX PHARMA PVT. LTD]5Current NDC, Legacy NDC, 2 package rows20231201_82771f6a-8b3d-4ffa-8b35-09c2faf3582c.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 117 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN82771f6a-8b3d-4ffa-8b35-09c2faf3582c5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD82771f6a-8b3d-4ffa-8b35-09c2faf3582c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76457-002-00764570002001 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLE1 bottle2018-02-090000-00-00NoNoCurrent