FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
0904-6985
11-digit product format
009046985
Labeler code
0904
Product ID
0904-6985_8e5db62b-075e-4ba2-a139-533be1166006
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-27
Marketing end
2027-05-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

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
0904-6985-16Diphenhydramine HCl473 mL in 1 BOTTLE, PLASTICSOLUTION47314
0904-6985-20Diphenhydramine HCl118 mL in 1 BOTTLE, PLASTICSOLUTION11814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6985-16ML - Milliliter0904-69856611c1f7-9ef0-4355-bd81-45259ef3f28e12019-10-07
0904-6985-20ML - Milliliter0904-698549dd2649-9d77-4191-9704-1731d6e2495612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6985DIPHENHYDRAMINE HCL SOLUTION [MAJOR PHARMACEUTICALS]11Current NDC, Legacy NDC, 2 package rows20240805_93753885-6add-462c-9df8-b0a1b9ce36c9.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 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCfe903448-b422-42e0-b05b-aeb3e5481e3c2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC1d4fcb76-22d1-7292-e063-6394a90af9202025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4478fd51-bae3-6108-e063-6394a90a07ca2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.395bb39a-e26f-f4f2-e063-6394a90ae7212025-11-25WarningsExact identifier
application number: M012
day timeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Beaf3af6a-de5b-43fe-83ff-9641646e0f6b2025-11-25WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLCe19b561c-fb76-4355-a306-d3dc46930bf22025-11-24WarningsExact identifier
application number: M012
Sinus DecongestionPSEUDOEPHEDRINE HCLKroger Company73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c2025-11-24WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN93753885-6add-462c-9df8-b0a1b9ce36c914
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD93753885-6add-462c-9df8-b0a1b9ce36c914
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY93753885-6add-462c-9df8-b0a1b9ce36c914
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY93753885-6add-462c-9df8-b0a1b9ce36c914
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY93753885-6add-462c-9df8-b0a1b9ce36c914
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNfa12a5a8-bf2d-4991-9d54-9c519e8e04cd5
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDfa12a5a8-bf2d-4991-9d54-9c519e8e04cd5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYfa12a5a8-bf2d-4991-9d54-9c519e8e04cd5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYfa12a5a8-bf2d-4991-9d54-9c519e8e04cd5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYfa12a5a8-bf2d-4991-9d54-9c519e8e04cd5
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNebf42e5e-df98-65e5-e053-2a95a90a7ac31
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNe2532bb9-5182-4017-92b2-e9ece60b48461
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDebf42e5e-df98-65e5-e053-2a95a90a7ac31
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDe2532bb9-5182-4017-92b2-e9ece60b48461
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYebf42e5e-df98-65e5-e053-2a95a90a7ac31
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYe2532bb9-5182-4017-92b2-e9ece60b48461
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYebf42e5e-df98-65e5-e053-2a95a90a7ac31
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYe2532bb9-5182-4017-92b2-e9ece60b48461
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYebf42e5e-df98-65e5-e053-2a95a90a7ac31
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYe2532bb9-5182-4017-92b2-e9ece60b48461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6985-1600904698516473 mL in 1 BOTTLE, PLASTIC (0904-6985-16) 473 ml2019-08-272027-04-30NoNoCurrent
0904-6985-2000904698520118 mL in 1 BOTTLE, PLASTIC (0904-6985-20) 118 ml2019-08-272027-05-31NoNoCurrent