NDC Code(s) : 50580-535-01, 50580-535-08
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Benadryl DYE-FREE ALLERGYDiphenhydramine hydrochloride SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-535
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
Product Characteristics
Color white (Clear, colorless) Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50580-535-011 in 1 CARTON 12/01/2015
1118 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
2NDC:50580-535-081 in 1 CARTON 16/06/2022
2236 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 07/01/2008

LABELER - Johnson & Johnson Consumer Inc.(878046358)

PRINCIPAL DISPLAY PANEL

NDC 50580-535-01

Children's
Benadryl ®

DYE-FREE ALLERGY

Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution

4-6 Hours/Dose

RELIEF OF:

  • Runny Nose
  • Sneezing
  • Itchy,Watery Eyes
  • Itchy Throat or Nose

✔ Free Of:

  • Dyes
  • Alcohol
  • Sugar
  • Parabens
  • High Fructose
    Corn Syrup

Bubble Gum!
Flavored Liquid

4 fl oz (118 mL)

Principal Display Panel