NDC 10237-766

Benzocaine, Menthol, Zinc Chloride

Orajel Instant Pain Relief Severe

Benzocaine, Menthol, Zinc Chloride is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine; Menthol; Zinc Chloride.

Product ID10237-766_4c0b14de-da1f-4c43-e054-00144ff88e88
NDC10237-766
Product TypeHuman Otc Drug
Proprietary NameBenzocaine, Menthol, Zinc Chloride
Generic NameOrajel Instant Pain Relief Severe
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-02-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch & Dwight Co., Inc.
Substance NameBENZOCAINE; MENTHOL; ZINC CHLORIDE
Active Ingredient Strength200 mg/g; mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-766-25

1 CARTON in 1 CARTON (10237-766-25) > 1 TUBE in 1 CARTON (10237-766-33) > 9.4 g in 1 TUBE
Marketing Start Date2017-02-20
Marketing End Date2021-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-766-25 [10237076625]

Benzocaine, Menthol, Zinc Chloride CREAM
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-20
Marketing End Date2021-12-17

NDC 10237-766-32 [10237076632]

Benzocaine, Menthol, Zinc Chloride CREAM
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-20
Marketing End Date2017-04-13

NDC 10237-766-33 [10237076633]

Benzocaine, Menthol, Zinc Chloride CREAM
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-20
Marketing End Date2021-12-17

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:4c0b14de-da1e-4c43-e054-00144ff88e88
Manufacturer
UNII

NDC Crossover Matching brand name "Benzocaine, Menthol, Zinc Chloride" or generic name "Orajel Instant Pain Relief Severe"

NDCBrand NameGeneric Name
10237-766Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
10237-768Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
10237-769Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
10237-770Benzocaine, Menthol, Zinc ChlorideOrajel Instant Pain Relief Severe
10237-771Benzocaine, Menthol, Zinc ChlorideOrajel Severe PM Toothache and Gum Relief
69842-331CVS Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
69842-334CVS Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
58552-135Giltuss BucalsepBenzocaine, Menthol, Zinc chloride
41250-552Meijer Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
10237-783Orajel 3X Medicated For All Mouth SoresBenzocaine, Menthol, Zinc Chloride
10237-723Orajel 3X Medicated for Denture PainBenzocaine, Menthol, Zinc Chloride
10237-790Orajel 3X Medicated For Toothache and GumBenzocaine, Menthol, Zinc chloride
10237-772Orajel Denture Pain ReliefBenzocaine, Menthol, Zinc Chloride
10237-778Orajel Denture Pain ReliefBenzocaine, Menthol, Zinc Chloride
10237-791Orajel Gum Pain 3X MedicatedBenzocaine, Menthol, Zinc chloride
10237-792Orajel Gum Pain 3X Medicatedbenzocaine, menthol, zinc chloride
11822-6037Rite Aid Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
11822-6038Rite Aid Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
0363-5350Walgreens Instant Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
0363-5351Walgreens Instant Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.