NDC 58552-135

Giltuss Bucalsep

Benzocaine, Menthol, Zinc Chloride

Giltuss Bucalsep is a Oral; Topical Spray in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Benzocaine; Menthol; Zinc Chloride.

Product ID58552-135_85053391-8d70-ab4f-e053-2991aa0a7e08
NDC58552-135
Product TypeHuman Otc Drug
Proprietary NameGiltuss Bucalsep
Generic NameBenzocaine, Menthol, Zinc Chloride
Dosage FormSpray
Route of AdministrationORAL; TOPICAL
Marketing Start Date2018-07-26
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameGil Pharmaceutical Corp
Substance NameBENZOCAINE; MENTHOL; ZINC CHLORIDE
Active Ingredient Strength7 g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-135-01

1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) > 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date2018-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-135-01 [58552013501]

Giltuss Bucalsep SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-07-26

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE6.5 g/100mL

OpenFDA Data

SPL SET ID:85053391-8d71-ab4f-e053-2991aa0a7e08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2121084

    • NDC Crossover Matching brand name "Giltuss Bucalsep" or generic name "Benzocaine, Menthol, Zinc Chloride"

    NDCBrand NameGeneric Name
    58552-135Giltuss BucalsepBenzocaine, Menthol, Zinc chloride
    69842-331CVS Severe Toothache and Gum ReliefBenzocaine, Menthol, Zinc chloride
    69842-334CVS Severe Toothache and Gum ReliefBenzocaine, 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
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