FDA.reportPublic FDA data

Banophen

Product NDC
71335-0081
11-digit product format
713350081
Labeler code
71335
Product ID
71335-0081_6129c299-3b41-4276-a828-d074abb1669e
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hcl
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-11-02
Marketing end
2028-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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
Banophen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477, 1020479

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
71335-0081-0Banophen12 in 1 BOTTLECAPSULE1211
71335-0081-1Banophen15 in 1 BOTTLECAPSULE1511
71335-0081-2Banophen20 in 1 BOTTLECAPSULE2011
71335-0081-3Banophen30 in 1 BOTTLECAPSULE3011
71335-0081-4Banophen10 in 1 BOTTLECAPSULE1011
71335-0081-5Banophen6 in 1 BOTTLECAPSULE611
71335-0081-6Banophen100 in 1 BOTTLECAPSULE10011
71335-0081-7Banophen90 in 1 BOTTLECAPSULE9011
71335-0081-8Banophen60 in 1 BOTTLECAPSULE6011
71335-0081-9Banophen2 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0081-2EA - Each71335-00819eaa95ce-9f65-4f93-992a-47e4d3c5e79612022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0081BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240510_20f00537-2c8a-45d1-8e5f-ec276d0a47b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020479BANOPHEN 50 MG Oral CapsulePSN20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020479diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen]SBD20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020479Banophen 50 MG Oral CapsuleSY20f00537-2c8a-45d1-8e5f-ec276d0a47b611
1020477diphenhydramine HCl 50 MG Oral CapsuleSY20f00537-2c8a-45d1-8e5f-ec276d0a47b611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0081-07133500810012 CAPSULE in 1 BOTTLE (71335-0081-0) 12 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-17133500810115 CAPSULE in 1 BOTTLE (71335-0081-1) 15 capsule2020-05-182028-01-31NoNoCurrent
71335-0081-27133500810220 CAPSULE in 1 BOTTLE (71335-0081-2) 20 capsule2018-04-202028-01-31NoNoCurrent
71335-0081-37133500810330 CAPSULE in 1 BOTTLE (71335-0081-3) 30 capsule2018-08-152028-01-31NoNoCurrent
71335-0081-47133500810410 CAPSULE in 1 BOTTLE (71335-0081-4) 10 capsule2019-09-092028-01-31NoNoCurrent
71335-0081-5713350081056 CAPSULE in 1 BOTTLE (71335-0081-5) 6 capsule2019-08-072028-01-31NoNoCurrent
71335-0081-671335008106100 CAPSULE in 1 BOTTLE (71335-0081-6) 100 capsule2018-05-072028-01-31NoNoCurrent
71335-0081-77133500810790 CAPSULE in 1 BOTTLE (71335-0081-7) 90 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-87133500810860 CAPSULE in 1 BOTTLE (71335-0081-8) 60 capsule2022-02-092028-01-31NoNoCurrent
71335-0081-9713350081092 CAPSULE in 1 BOTTLE (71335-0081-9) 2 capsule2022-02-092028-01-31NoNoCurrent