NDC 10237-756

Orajel for Cold Sores Single Dose

Benzalkonium Chloride, Benzocaine

Orajel for Cold Sores Single Dose is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzalkonium Chloride; Benzocaine.

• Product ID: 10237-756_7d7807a0-a6fc-b75b-e053-2991aa0a31d1
• NDC: 10237-756
• Product Type: Human Otc Drug
• Proprietary Name: Orajel for Cold Sores Single Dose
• Generic Name: Benzalkonium Chloride, Benzocaine
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-07-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Church & Dwight Co., Inc.
• Substance Name: BENZALKONIUM CHLORIDE; BENZOCAINE
• Active Ingredient Strength: 0 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10237-756-04

2 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-756-04) > .02 g in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2012-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-756-08 [10237075608]

Orajel for Cold Sores Single Dose LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01
• Marketing End Date: 2018-12-20

NDC 10237-756-03 [10237075603]

Orajel for Cold Sores Single Dose LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01
• Marketing End Date: 2019-12-18

NDC 10237-756-04 [10237075604]

Orajel for Cold Sores Single Dose LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01

NDC 10237-756-02 [10237075602]

Orajel for Cold Sores Single Dose LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-07-01
• Marketing End Date: 2018-12-20

Drug Details

Active Ingredients

Ingredient	Strength
BENZALKONIUM CHLORIDE	.13 mg/g

OpenFDA Data

• SPL SET ID: 05efbe22-2fed-42e3-a181-65558805cb2a
• Manufacturer:
  • Church & Dwight Co., Inc.
• UNII:
  • F5UM2KM3W7
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 1301152
  • 1301158
• UPC Code:
  • 0310310998813

NDC Crossover Matching brand name "Orajel for Cold Sores Single Dose" or generic name "Benzalkonium Chloride, Benzocaine"

NDC	Brand Name	Generic Name
51532-5300	Antiseptic	benzalkonium chloride, benzocaine
51532-5301	Antiseptic	benzalkonium chloride, benzocaine
61010-5300	Antiseptic	benzalkonium chloride, benzocaine
69103-5300	Antiseptic	benzalkonium chloride, benzocaine
73598-0681	Antiseptic	benzalkonium chloride, benzocaine
81238-5300	aramark Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE
51532-4616	CUT CLEANER	BENZALKONIUM CHLORIDE, BENZOCAINE
81238-4616	CUT CLEANER	BENZALKONIUM CHLORIDE, BENZOCAINE
50332-0212	First Aid	Benzalkonium Chloride, Benzocaine
62985-5081	First Aid Antiseptic	benzalkonium chloride, benzocaine
0498-0015	North First Aid Antiseptic	Benzalkonium Chloride, Benzocaine
10237-798	Orajel Cold Sore Touch Free - Single Dose	Benzalkonium Chloride, Benzocaine
10237-741	Orajel for Cold Sores	Benzalkonium Chloride, Benzocaine
10237-756	Orajel for Cold Sores	Benzalkonium Chloride, Benzocaine
67659-150	Orajel for Cold Sores	Benzalkonium Chloride, Benzocaine