FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
63187-866
11-digit product format
631870866
Labeler code
63187
Product ID
63187-866_d27b1389-9287-4f39-91de-0d76a87f4e05
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

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
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e91b9c3-57e8-488b-ac70-d863cdf9d6e8Available on FDA.report

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
63187-866-10Diphenhydramine HCL10 in 1 BOTTLE, PLASTICCAPSULE105
63187-866-30Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE305
63187-866-60Diphenhydramine HCL60 in 1 BOTTLE, PLASTICCAPSULE605
63187-866-90Diphenhydramine HCL90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-866-30EA - Each63187-866fc05308c-f8cc-4834-8e27-c6d7bc05127c12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-866DIPHENHYDRAMINE HCL CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20240201_6e91b9c3-57e8-488b-ac70-d863cdf9d6e8.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 133 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC53b15e75-9efd-4b4b-834b-6e9f12c601082024-12-02WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corpac8a14ac-7023-1e23-e053-2995a90aea3a2024-11-28WarningsExact identifier
application number: M012
Childrens Benadryl DYE-FREE ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC10d478ff-ddc6-45da-87ff-cfe1b2b07a8e2024-11-27WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
application number: M012
Severe Sinus Congestion Allergy and Cough FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC36a4ec1f-50c3-4d61-ada9-987ccad3563c2024-11-26WarningsExact identifier
application number: M012
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact identifier
application number: M012
NightTime SinusACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.0f3b1404-9252-470a-aa8c-b360c85731f32024-11-25WarningsExact identifier
application number: M012
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine HCl 50 MG Oral CapsuleSY6e91b9c3-57e8-488b-ac70-d863cdf9d6e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-866-106318708661010 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-10) 10 capsule2020-07-100000-00-00NoNoCurrent
63187-866-306318708663030 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-30) 30 capsule2017-06-010000-00-00NoNoCurrent
63187-866-606318708666060 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-60) 60 capsule2017-06-010000-00-00NoNoCurrent
63187-866-906318708669090 CAPSULE in 1 BOTTLE, PLASTIC (63187-866-90) 90 capsule2017-06-010000-00-00NoNoCurrent