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 157 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEAmerican Health Packaging4cd8aee3-5522-434b-a1b1-9591bed3e9a62024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging8632a655-7f5b-450f-95fa-62478a174e9c2024-08-04WarningsExact identifier
application number: M012
Guaifenesin DMGUAIFENESIN AND DEXTROMETHORPHANAmerican Health Packaging990906b3-c566-4f35-923c-060202ba48e02024-08-04WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropsHONEY LEMON FLAVOR MENTHOLWHOLE FOODS MARKET, INC.1eb7abdc-061f-0e18-e063-6294a90a3a652024-08-02WarningsExact identifier
application number: M012
Herbal Flavor Menthol Cough DropsHERBAL FLAVOR MENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb848b6-3dec-5b5f-e063-6394a90aea142024-08-02WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOL COUGH DROPSWHOLE FOODS MARKET, INC.1eb8927b-22c5-2ca3-e063-6294a90aa5632024-08-02WarningsExact identifier
application number: M012
No Drip Severe Anefrin Nasal0.05% OXYMETAZOLINE HCLWalgreens Companyc126e969-56f3-47b4-a011-02ff150eccb82024-08-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation90e0426b-654f-4bcd-8b1d-cf56d1fc0c682024-07-27WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HCLA-S Medication Solutions0e81a937-59e5-4869-8ffb-c758fb37230d2024-07-23WarningsExact identifier
application number: M012
WesTussin DMDEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWestminster Pharmaceuticals, LLC68a0cd44-3fdd-430e-af1a-498d4415ab782024-07-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGLil' Drug Store Products, Inc.edc244d6-eb0b-d3c9-e053-2a95a90a26222024-07-22WarningsExact identifier
application number: M012
Night Time Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1f3eeb6c-4c44-4e2a-ad72-12c95e6589c92024-07-22WarningsExact identifier
application number: M012
CareOne Childrens Allergy ReliefDIPHENHYDRAMINE HCLAmerican Sales Companybb78ef2c-4f42-4e8f-b38d-f9b2965a384b2024-07-19WarningsExact identifier
application number: M012
dg health allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, LLC71445443-34bd-4d8c-b9c8-e7c3b8d4c8322024-07-19WarningsExact identifier
application number: M012
basic care childrens allergy reliefDIPHENHYDRAMINE HCLAmazon.com Services LLC75b9ee90-ad26-433e-8b90-97441b8d1e152024-07-19WarningsExact identifier
application number: M012
Cold and Flu Severe Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC9b74dd00-8f84-4fce-b5ea-df886b5953262024-07-18WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
application number: M012
equate allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb05acd16-21cb-4ee0-afa0-8f7d591664352024-07-18WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLPublix Super Markets Inccc6e4e26-84f5-4003-b1eb-f0e06d3e294e2024-07-18WarningsExact identifier
application number: M012
childrens allergyDIPHENHYDRAMINE HYDROCHLORIDEKroger Company10ebc7f8-dc8a-4640-8f87-d0d073998fd52024-07-18WarningsExact 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