FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
68788-8855
11-digit product format
687888855
Labeler code
68788
Product ID
68788-8855_9382c976-3067-4923-a38f-101d1c481e97
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-11
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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9382c976-3067-4923-a38f-101d1c481e97Available 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
68788-8855-0Diphenhydramine Hydrochloride10 in 1 BOTTLECAPSULE101
68788-8855-1Diphenhydramine Hydrochloride15 in 1 BOTTLECAPSULE151
68788-8855-3Diphenhydramine Hydrochloride30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8855-0EA - Each68788-88559a25d52b-63c5-4caf-9af5-0eb9193650a712025-07-08
68788-8855-1EA - Each68788-885590da6c69-9ed7-4ef5-a13f-e7a6a0605cf412025-07-08
68788-8855-3EA - Each68788-88559cfd9f0b-f780-4b06-b659-bd599fda1ee812025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8855DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250413_9382c976-3067-4923-a38f-101d1c481e97.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 64 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Sore Throat LozengesBENZOCAINEBestco Inc.737efd41-2d59-6013-e053-2a91aa0a6c632025-12-31WarningsExact identifier
application number: M012
Best Health Menthol Cough DropsMENTHOLBestco LLCdda66a3c-9006-ff1a-e053-2a95a90abfb32025-12-31WarningsExact identifier
application number: M012
Rynex DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEdwards Pharmaceuticals, Inc7be2c282-24ba-4f19-9b14-872d3f5746a72025-12-31WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLWal-Mart Stores Incf51d1d52-39c2-4259-8b30-f9ac21edb2652025-12-31WarningsExact identifier
application number: M012
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINRUGBY LABORATORIES51b088bc-b44f-44b9-a08e-133509a35a2c2025-12-30WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRUGBY LABORATORIES60c9e493-f58c-45d6-bade-c952975124032025-12-30WarningsExact identifier
application number: M012
BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAdvanced Generic Corporatione48e46e3-d3fa-4b25-8b07-bbecc4f0b64b2025-12-30WarningsExact identifier
application number: M012
AltitussDEXTROMETHORPHAN HBR, GUAIFENESINAlternative Pharmacal Corporatione4ac96f5-2a3a-42a8-8db5-80de4dcdbd442025-12-30WarningsExact identifier
application number: M012
BiocofDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d62025-12-30WarningsExact identifier
application number: M012
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
application number: M012
AltipresDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAlternative Pharmacal Corporationc5a43107-3eb8-46bb-87bd-20deafe28c3f2025-12-30WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.d02f32c1-716e-4753-abba-ff97c4dc9e222025-12-30WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
application number: M012
NinjacofCHLOPHEDIANOL HCL AND PYRILAMINE MALEATECenturion Labs, LLCe2bca40f-9c27-ec8b-2ff0-ef9847ba20372025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079194-b5e7-d5e6-e063-6394a90a4d8c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307db15-592b-138a-e063-6394a90a23a52025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23087ee3-26a0-e2b8-e063-6394a90abef42025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREECOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.230883da-de48-68e9-e063-6394a90a927c2025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9382c976-3067-4923-a38f-101d1c481e971
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9382c976-3067-4923-a38f-101d1c481e971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8855-06878888550010 CAPSULE in 1 BOTTLE (68788-8855-0) 10 capsule2025-04-11NoNoCurrent
68788-8855-16878888550115 CAPSULE in 1 BOTTLE (68788-8855-1) 15 capsule2025-04-11NoNoCurrent
68788-8855-36878888550330 CAPSULE in 1 BOTTLE (68788-8855-3) 30 capsule2025-04-11NoNoCurrent