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 45 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINBryant Ranch Prepack1e9887f6-209f-4f1f-9afa-a5ca649721cb2026-03-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamora Inc.5a7bf4cd-1d44-424d-9ef4-d484e626e3262026-03-18WarningsExact identifier
application number: M012
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
application number: M012
Harris Teeter Cherry Cough DropsMENTHOLHarris Teeter4d50cc62-c84f-0761-e063-6394a90af54a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter Honey Lemon Cough DropsMENTHOLHarris Teeter4d516fce-d219-eee9-e063-6294a90ac59a2026-03-18WarningsExact identifier
application number: M012
Harris Teeter SF Honey Lemon Cough DropsMENTHOLHarris Teeter4d524b45-260e-7411-e063-6294a90af6392026-03-18WarningsExact identifier
application number: M012
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEBryant Ranch Prepack9a77465c-6d3a-4399-9734-ad22e4b435db2026-03-18WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPreferred Pharmaceuticals Inc.a56d2fe4-5bea-4668-8e66-5a6f4279d4612026-03-18WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leader4136e5f4-cc00-46d6-aa7f-ef56d087d7ec2026-03-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf9a0fb35-46d6-434f-8f9a-425a4bf50e842026-03-18WarningsExact identifier
application number: M012
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEGrocery Outlet7398a372-7679-423b-a3ca-8da905a979dd2026-03-17WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGrocery Outlet0661ddeb-6289-471e-af89-7f4b7452c3552026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Cough Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS2cf361eb-6055-2364-e063-6294a90a69a12026-03-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYb024ab38-e5da-4f5a-888f-e2a2815782902026-03-16WarningsExact identifier
application number: M012
good neighbor pharmacy night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen41f87d59-3245-46dc-88a8-b947675a90fc2026-03-16WarningsExact identifier
application number: M012
Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCLCVS2bc3eae8-ffe6-bc96-e063-6394a90a22832026-03-16WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP23e2d2dc-12d4-294d-e063-6394a90a95232026-03-16WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS Pharmacy48438525-e49f-9303-e063-6394a90a44f22026-03-16WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, GUAIFENESINCVS HEALTH CORP4985c332-6602-fd2d-e063-6394a90accd22026-03-16WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nighttime SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy4981bbcd-7178-335f-e063-6394a90ae9612026-03-16WarningsExact 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