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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORIGINAL Nasal PUMP MIST No DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCac27fd75-4fe4-433c-a434-2dac16c895c72026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsExact identifier
application number: M012
Severe Congestion Nasal Anti-Drip Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCa09c2d02-334a-4840-b2d0-327121cec9942026-08-07WarningsExact identifier
application number: M012
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
application number: M012
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
application number: M012
Sine Aid PEAK MISERYOXYMETAZOLINE HYDROCHLORIDEInfirst Healthcare Inc.586a2a14-7048-0c8b-e063-6394a90a65b72026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast DissolveCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.507284c3-cad9-d65c-e063-6394a90a58a82026-08-05WarningsExact identifier
application number: M012
cough and cold relief HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRUnited Natural Foods, Inc. dba UNFI90482e7a-d7c7-4127-972d-5ee55e55ed1c2026-08-04WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRBetter Living Brands, LLC33f34aa2-3b37-4e51-8428-4a12708aa0642026-08-04WarningsExact 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