FDA.reportPublic FDA data

PHARBEDRYL

Product NDC
73057-347
11-digit product format
730570347
Labeler code
73057
Product ID
73057-347_2c2777c1-a456-d152-e063-6294a90a7539
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 50mg
Dosage form
CAPSULE
Route
ORAL
Labeler
Ulai Health LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-02
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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
PHARBEDRYL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-347-082022-01-31C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-112022-01-31C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-082022-01-28C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-112022-01-28C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-347-08PHARBEDRYL100 in 1 BOTTLE, PLASTICCAPSULE1003
73057-347-11PHARBEDRYL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-347PHARBEDRYL (DIPHENHYDRAMINE HCL 50MG) CAPSULE [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250122_135293fb-5674-4638-be55-b968cf51257e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN135293fb-5674-4638-be55-b968cf51257e3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD135293fb-5674-4638-be55-b968cf51257e3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY135293fb-5674-4638-be55-b968cf51257e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73057-347-0873057034708100 CAPSULE in 1 BOTTLE, PLASTIC (73057-347-08) 100 capsule2019-07-020000-00-00NoNoCurrent
73057-347-11730570347111000 CAPSULE in 1 BOTTLE, PLASTIC (73057-347-11) 1000 capsule2019-07-020000-00-00NoNoCurrent