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 135 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact 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