FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
54738-116
11-digit product format
547380116
Labeler code
54738
Product ID
54738-116_2a328f44-efc3-7e72-e063-6394a90a1d39
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Richmond Pharmaceuticals Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-02-15
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
2026-12-31
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 Hydrochloride
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020477Internal RxNorm lookup
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f184b2aa-91a4-44f9-b688-d4e318181984Available 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
54738-116-13Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1005
54738-116-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1002
54738-116-03Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-116-01EA - Each54738-116de51d6f9-9d96-4ca6-a402-797d803b061f12017-11-06
54738-116-03EA - Each54738-1162375fe3e-94f9-4410-ba4b-38af72221de312017-11-06
54738-116-13EA - Each54738-116f14c9574-5961-47ef-b3d1-da2fac68a61a12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-116DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20241228_f184b2aa-91a4-44f9-b688-d4e318181984.zip
54738-116DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [RICHMOND PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20171030_ab67121e-2477-47dd-a7ec-114453df3fd4.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 37 of 180 · 3,584 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf184b2aa-91a4-44f9-b688-d4e3181819845
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNf184b2aa-91a4-44f9-b688-d4e3181819845
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf184b2aa-91a4-44f9-b688-d4e3181819845
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDf184b2aa-91a4-44f9-b688-d4e3181819845
1020477diphenhydramine HCl 50 MG Oral CapsuleSYf184b2aa-91a4-44f9-b688-d4e3181819845
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNab67121e-2477-47dd-a7ec-114453df3fd42
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDab67121e-2477-47dd-a7ec-114453df3fd42
1020477diphenhydramine HCl 50 MG Oral CapsuleSYab67121e-2477-47dd-a7ec-114453df3fd42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54738-116-0154738011601100 CAPSULE in 1 BOTTLE (54738-116-01) 100 capsule2015-05-010000-00-00NoNoCurrent
54738-116-03547380116031000 CAPSULE in 1 BOTTLE (54738-116-03) 1000 capsule2015-05-010000-00-00NoNoCurrent
54738-116-1354738011613100 CAPSULE in 1 BOTTLE (54738-116-13) 100 capsule2000-02-150000-00-00NoNoCurrent