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 78 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vaporizing RubCAMPHOR, EUCALYPTUS OIL AND MENTHOLALAINA HEALTHCARE PRIVATE LIMITED4c6a7ac0-be76-42b0-9a08-b287e70a34602025-12-09WarningsExact identifier
application number: M012
24-7 Life BY 7-ELEVEN Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTIONLil' Drug Store products, Inc.277363f4-1c00-ddb7-e063-6294a90a46772025-12-09WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief, 24-7 Life BY 7-ElevenACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTIONLil' Drug Store Products, Inc.2771d699-3f70-4318-e063-6394a90a89cc2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b2025-12-09WarningsExact identifier
application number: M012
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc9a32bc6d-0499-48fa-a6ad-702c8a28bf5f2025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp5015a380-a229-4eff-8e31-528065c6ed642025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teetercaf59320-5b48-4533-bda9-7b03a2fde0b52025-12-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
application number: M012
Walgreens Childrens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a7226-84b9-26d7-e063-6394a90a99b92025-12-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINMeijer Distribution Inc8ed5b802-a26e-45b4-a696-bc64dbac47332025-12-09WarningsExact identifier
application number: M012
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEFamily Dollar (FAMILY WELLNESS)2c431220-c61b-4ad5-9ad2-58ccaee2d1c32025-12-09WarningsExact identifier
application number: M012
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fdd0dadc-5313-4f6e-aef5-ca853efe5c4d2025-12-08WarningsExact identifier
application number: M012
MucolyteGUAIFENESINRising Pharma Holdings, Inc.e4091aaf-44e3-4701-9986-aff248a2f1b82025-12-08WarningsExact identifier
application number: M012
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLAmerican Sales47f504d5-3ec5-5227-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLAmerican Sales4893ac0a-7769-5657-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLAmerican Sales45e891ea-2f2a-31b7-e054-00144ff88e882025-12-07WarningsExact 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