FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
0904-7559
11-digit product format
009047559
Labeler code
0904
Product ID
0904-7559_45b07e82-0ce9-492f-8303-65c992c7dc32
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
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 HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/10mL

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
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b591e27-b00b-41c8-9fe9-c633aba09134Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7559-66Diphenhydramine HCl10 mL in 1 CUP, UNIT-DOSESOLUTION102
0904-7559-72Diphenhydramine HCl10 in 1 CASESOLUTION102
0904-7559-72Diphenhydramine HCl10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7559-66ML - Milliliter0904-75597d00a455-73c9-4a2e-b44f-ad1385554e6712025-09-12
0904-7559-72ML - Milliliter0904-7559e16d02ce-aa1f-40b5-bf7b-d8daa291946b12025-09-12

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 121 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
application number: M012
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
application number: M012
Extra Strength Nite-Time Pain Relief430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLETWALGREENSc25cff5a-93f5-62aa-e053-2a95a90aa7b42025-01-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALGREENSdbf5c814-4e69-13ac-e053-2a95a90a49a32025-01-30WarningsExact identifier
application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWALGREENSf3770976-de73-52b8-e053-2995a90aad4f2025-01-30WarningsExact identifier
application number: M012
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26c82bc3-5753-4d56-96a4-a3f9c8c267d02025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8095b211-8ae7-44e5-b89a-b7f730e28d512025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2cf2f35b-5d59-e3ff-e063-6294a90a9b452025-01-30WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c52025-01-30WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cold and FluACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDERB Health (US) LLC2ce20ab5-5f2d-1c97-e063-6394a90ad67b2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals97b137c9-0bec-409a-91f7-e298c296578b2025-01-29WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCVS1dc17665-62ce-f7f5-e063-6294a90af8512025-01-29WarningsExact identifier
application number: M012
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1b591e27-b00b-41c8-9fe9-c633aba091342
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1b591e27-b00b-41c8-9fe9-c633aba091342
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1b591e27-b00b-41c8-9fe9-c633aba091342
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1b591e27-b00b-41c8-9fe9-c633aba091342
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1b591e27-b00b-41c8-9fe9-c633aba091342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7559-660090475596610 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0904-7559-720090475597210 TRAY in 1 CASE (0904-7559-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66) 10 tray2025-08-01NoNoCurrent