FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
72789-317
11-digit product format
727890317
Labeler code
72789
Product ID
72789-317_56d551ca-b3ee-5d72-e063-6294a90af6c8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-14
Marketing end
2028-04-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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 Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 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
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
879a7804-f3d4-4a3d-bc92-b473499d6c95Available 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
72789-317-10Diphenhydramine Hydrochloride10 in 1 BOTTLE, PLASTICCAPSULE106
72789-317-12Diphenhydramine Hydrochloride12 in 1 BOTTLE, PLASTICCAPSULE126
72789-317-15Diphenhydramine Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE156
72789-317-20Diphenhydramine Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE206
72789-317-30Diphenhydramine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-317-10EA - Each72789-317f73d9a2f-5d75-44a8-9b88-a6002474c00f12023-06-06
72789-317-12EA - Each72789-3172464e553-8f01-4953-a4b5-43e849652c0912023-06-06
72789-317-15EA - Each72789-31743a8de8b-5675-4f49-905b-f4b4f9b2e1fe12023-06-06
72789-317-20EA - Each72789-317d8399382-8242-44a4-b03d-72fef2afcbc712023-06-06
72789-317-30EA - Each72789-317f3bbd72e-fe79-4c59-a9b9-412ef69161a012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-317DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]5Current NDC, 5 package rows20250221_879a7804-f3d4-4a3d-bc92-b473499d6c95.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 74 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SF Honey Lemon Cough DropsMENTHOLThe Kroger Co.43281bd1-f8a7-02a4-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Kroger Cherry Cough DropsMENTHOLKrogera2e1d1f5-9b19-1704-e053-2a95a90abb512025-12-17WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CF AdultDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEMajor Pharmaceuticalsa9958b7d-7060-422b-a098-c1925c2460812025-12-17WarningsExact identifier
application number: M012
Childrens Mucus Relief Cough Cherry LiquidDEXTROMETHORPHAN HBR, GUAIFENSINTopco Associates3170748e-b09f-4c07-9927-df43771166c52025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe2025-12-16WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e70d0784-53bc-4910-aade-3c9ad6e364412025-12-16WarningsExact identifier
application number: M012
Pain and SinusACETAMINOPHEN AND PHENYLEPHRINEJHK Inc dba American Safety & First Aid88f86f5a-cc2b-4c75-b7a4-f2021922280b2025-12-16WarningsExact identifier
application number: M012
Severe Congestion and Cough, Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Companyb75af815-9bd4-4a7a-bc68-f42f4af506992025-12-16WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fe5fd29e-7f81-4633-8c3b-010d68abe7012025-12-16WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHarris Teeter, LLCe0a62fa1-9f8a-4770-b28b-1f4f02a762e02025-12-16WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company8c4b59b8-dfab-4f4a-9966-f07b026a758a2025-12-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)df866cf6-0526-4e61-ac9b-245b57dd5df62025-12-16WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensc89200b6-4adb-452e-b931-07f631dad6412025-12-16WarningsExact identifier
application number: M012
ONESSIP ADULT DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIMEDWISE LIFESCIENCES INC.45fa9159-d74c-063a-e063-6294a90a3ed02025-12-15WarningsExact identifier
application number: M012
SudoGest Nasal DecongestantPSEUDOEPHEDRINE HCLMajor Pharmaceuticals5229f4b2-a194-46f8-a0bc-4510fbe520752025-12-15WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf2b2467f-2d9b-4742-b90a-95975c3b694f2025-12-13WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLHEB39178eb7-ada9-30bf-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLHEB3a443179-b7a6-3242-e054-00144ff8d46c2025-12-13WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLHEB39bd0ca1-348f-0ce1-e054-00144ff88e882025-12-13WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLHEB766236e2-3302-2232-e053-2991aa0af5032025-12-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN879a7804-f3d4-4a3d-bc92-b473499d6c956
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD879a7804-f3d4-4a3d-bc92-b473499d6c956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-317-107278903171010 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10) 10 capsule2023-04-052028-02-29NoNoHistorical
72789-317-127278903171212 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12) 12 capsule2023-04-052028-02-29NoNoHistorical
72789-317-157278903171515 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15) 15 capsule2023-04-052028-02-29NoNoHistorical
72789-317-207278903172020 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20) 20 capsule2023-04-052028-02-29NoNoHistorical
72789-317-307278903173030 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30) 30 capsule2023-04-052028-02-29NoNoHistorical