FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
72789-317
11-digit product format
727890317
Labeler code
72789
Product ID
72789-317_4bbc599b-b951-6949-e063-6394a90ad9fc
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
2028-02-29
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

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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

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