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 56 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Seacall Nasal Spray.NASAL SPRAYGuangdong Quadrant Ecological Technology Co., Ltd.1f12618b-7461-fb47-e063-6294a90af7532026-01-23WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf7d210-102c-4053-81f6-67116de6cf7b2026-01-23WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Day TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmerisource Bergen44f9255b-0bf9-4573-ac9c-410acb515bc22026-01-23WarningsExact identifier
application number: M012
Daytime cold and flu non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMeijer Distribution Inc29caa3a7-7fe6-4134-a9b0-49bdb9280ca72026-01-23WarningsExact identifier
application number: M012
good neighbor pharmacy night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergene2b5c27e-ca5f-4503-a3ce-c86e1d8070a72026-01-23WarningsExact identifier
application number: M012
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M012
DRX CHOICE NIGHTTIME COLD and FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATERaritan Pharmaceuticals Inc.f466fc0e-3384-4884-832e-99bf1fdcf8992026-01-21WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR GUAIFENESINStrategic Sourcing Services LLC84750bfb-9e94-40a3-b731-21799f5e4fd12026-01-20WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRAmerisource Bergen0b58990f-2246-408e-9365-51f56bb6766c2026-01-20WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATECARDINAL HEALTH 110, LLC. DBA LEADER 70000a8460fc9-2d08-4e5f-8dd3-5135ecda59232026-01-20WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services Inc0a651316-623e-41eb-ab3a-641f5d8074252026-01-20WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non Drowsy Day and Night Cold and FluWALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLUWalgreens579c47c8-6366-4785-9680-d3986ce9641d2026-01-19WarningsExact identifier
application number: M012
Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and ColdWALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLDWalgreensdd61c9d3-0b70-450e-9525-282710b383cc2026-01-19WarningsExact identifier
application number: M012
Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC48bf7422-38ef-d4b4-e063-6294a90aa3ab2026-01-19WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreensfc670515-a820-4ea7-8786-8ae710798b312026-01-19WarningsExact identifier
application number: M012
Allergy Relief Dye FreeDIPHENHYDRAMINE HCLWALGREENS9dece7b1-00b1-2499-e053-2a95a90a0be32026-01-19WarningsExact identifier
application number: M012
SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreens2dba2bec-e0e3-4910-89c5-ebc093e05bec2026-01-19WarningsExact identifier
application number: M012
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVEREACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreensca3c1eb4-6099-5e5f-e053-2995a90ab61b2026-01-19WarningsExact identifier
application number: M012
SEVERE NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEWALGREENSfe6dff90-18f1-491e-84b9-cc74bb1831ba2026-01-19WarningsExact identifier
application number: M012
Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens Companyec8c73d5-b190-432a-92c6-68ea0fc86ea62026-01-19WarningsExact 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