BANOPHEN DIPHENHYDRAMINE HCL

Product NDC
61919-174
Requested package NDC
61919-174-90
11-digit product format
619190174
Labeler code
61919
Product ID
61919-174_b9469dad-3958-2e41-e053-2a95a90abd26
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-01-19
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-174-20EA - Each61919-174169244f6-9075-4c81-ab95-49817c3f321212021-02-05
61919-174-30EA - Each61919-1747cf9bfdd-25b0-4e83-8ebb-e220d2b82a5f12021-02-05
61919-174-90EA - Each61919-174b24bd86c-be5a-4adf-b991-ed1e1fc7053d12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-174-906191901749090 CAPSULE in 1 BOTTLE (61919-174-90) 90 capsule2021-01-190000-00-00NoNoCurrent