FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
71335-2257
11-digit product format
713352257
Labeler code
71335
Product ID
71335-2257_00ce4a39-6dad-4e7d-878a-a34b3a06f92d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-14
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

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
71335-2257-0Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE100102
71335-2257-1Diphenhydramine Hydrochloride30 in 1 BOTTLECAPSULE30102
71335-2257-2Diphenhydramine Hydrochloride20 in 1 BOTTLECAPSULE20102
71335-2257-3Diphenhydramine Hydrochloride42 in 1 BOTTLECAPSULE42102
71335-2257-4Diphenhydramine Hydrochloride24 in 1 BOTTLECAPSULE24102
71335-2257-5Diphenhydramine Hydrochloride15 in 1 BOTTLECAPSULE15102
71335-2257-6Diphenhydramine Hydrochloride60 in 1 BOTTLECAPSULE60102
71335-2257-7Diphenhydramine Hydrochloride10 in 1 BOTTLECAPSULE10102
71335-2257-8Diphenhydramine Hydrochloride6 in 1 BOTTLECAPSULE6102
71335-2257-9Diphenhydramine Hydrochloride90 in 1 BOTTLECAPSULE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2257-1EA - Each71335-225758b99513-9485-4de7-a0e3-2551287c0f4a12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2257DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 10 package rows20250228_f40bfdfc-1cb4-4604-9790-fb8d1d5173c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf40bfdfc-1cb4-4604-9790-fb8d1d5173c6102
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf40bfdfc-1cb4-4604-9790-fb8d1d5173c6102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2257-071335225700100 CAPSULE in 1 BOTTLE (71335-2257-0) 100 capsule2025-01-31NoNoCurrent
71335-2257-17133522570130 CAPSULE in 1 BOTTLE (71335-2257-1) 30 capsule2023-11-08NoNoCurrent
71335-2257-27133522570220 CAPSULE in 1 BOTTLE (71335-2257-2) 20 capsule2024-06-18NoNoCurrent
71335-2257-37133522570342 CAPSULE in 1 BOTTLE (71335-2257-3) 42 capsule2025-01-31NoNoCurrent
71335-2257-47133522570424 CAPSULE in 1 BOTTLE (71335-2257-4) 24 capsule2024-05-21NoNoCurrent
71335-2257-57133522570515 CAPSULE in 1 BOTTLE (71335-2257-5) 15 capsule2024-04-22NoNoCurrent
71335-2257-67133522570660 CAPSULE in 1 BOTTLE (71335-2257-6) 60 capsule2025-01-31NoNoCurrent
71335-2257-77133522570710 CAPSULE in 1 BOTTLE (71335-2257-7) 10 capsule2025-01-31NoNoCurrent
71335-2257-8713352257086 CAPSULE in 1 BOTTLE (71335-2257-8) 6 capsule2025-01-31NoNoCurrent
71335-2257-97133522570990 CAPSULE in 1 BOTTLE (71335-2257-9) 90 capsule2025-01-31NoNoCurrent