Orajel Cold Sore Touch Free - Single Dose

Product NDC: 10237-798
11-digit product format: 102370798
Labeler code: 10237
Product ID: 10237-798_51b6fb8e-eeba-a04a-e063-6294a90a610f
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride, Benzocaine
Dosage form: LIQUID
Route: TOPICAL
Labeler: Church & Dwight Co., Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-01
Substance: BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength: 1.3; 50 mg/mL; mg/mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-798-35	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10237-798-35	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Orajel Cold Sore Touch Free - Single Dose
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/mL
BENZOCAINE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2572114	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ce40829e-941f-2548-e053-2995a90a1e0e	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-11-27	Orajel Cold Sore Touch Free - Single Dose
2024-11-27	Orajel Cold Sore Touch Free - Single Dose
2024-07-30	Orajel Cold Sore Touch Free - Single Dose
2024-07-30	Orajel Cold Sore Touch Free - Single Dose
2024-02-06	Orajel Cold Sore Touch Free - Single Dose
2024-02-06	Orajel Cold Sore Touch Free - Single Dose
2023-01-30	Orajel Cold Sore Touch Free - Single Dose
2023-01-30	Orajel Cold Sore Touch Free - Single Dose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10237-798-35	Orajel Cold Sore Touch Free - Single Dose	3.5 mL in 1 VIAL, SINGLE-DOSE	LIQUID	3.5		6
10237-798-35	Orajel Cold Sore Touch Free - Single Dose	6 in 1 PACKAGE	LIQUID	6		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10237-798	ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250330_ce40829e-941f-2548-e053-2995a90a1e0e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35ac19-6883-a733-e063-6294a90ad22d	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	cfe8114b-df65-064b-e053-2a95a90a33f6	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Exact identifier application number: M017
Licefreee AfterLice	PRAMOXINE HCI	Tec Laboratories Inc.	06c4cc42-a215-3949-e063-6394a90a665e	2024-11-05	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	ASO LLC	cb9505b7-222d-3a24-e053-2a95a90a0b64	2024-11-05	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Exact identifier application number: M017
Eagle Green Balm	CAMPHOR MENTHOL	Borden Company (Private) Limited	6f7a796b-a31c-0e60-e053-2a91aa0a022b	2024-11-04	Warnings	Exact identifier application number: M017
Muscular Balm	CAPSAICIN MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	ed79f14e-6b3d-4bf2-9c34-d019c1ba2582	2024-11-04	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	A-S Medication Solutions	3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e3	2024-11-04	Warnings	Exact identifier application number: M017
Walgreens Ice Blue Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Walgreen Company	1c0ee442-ffd2-4f6c-aab2-f70e295378ad	2024-11-04	Warnings	Exact identifier application number: M017
Walgreen Cool n Heat Maximum Strength Pain Relieving	MENTHOL, UNSPECIFIED FORM	Walgreen Company	d5c79476-dde8-4a85-8878-bc2ac3a3d70b	2024-11-04	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE	STRATUS PHARMACEUTICALS INC	87a4f559-a4f6-4b9f-98de-b55b073a11c6	2024-11-01	Warnings	Exact identifier application number: M017
Walgreens Nerve Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Walgreen Company	83849eca-e02f-4b43-b3a7-b25e987e08a8	2024-10-31	Warnings	Exact identifier application number: M017
Sanar Naturals Arnica White	CAMPHOR	Sanvall Enterprises, Inc	192039a2-aed6-821b-e063-6394a90a7f29	2024-10-31	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2572114	benzalkonium chloride 0.13 % / benzocaine 5 % Topical Solution	PSN	ce40829e-941f-2548-e053-2995a90a1e0e	6
2572114	benzalkonium chloride 1.3 MG/ML / benzocaine 50 MG/ML Topical Solution	SCD	ce40829e-941f-2548-e053-2995a90a1e0e	6
2572114	benzalkonium chloride 0.13 % / benzocaine 5 % Topical Solution	SY	ce40829e-941f-2548-e053-2995a90a1e0e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10237-798-35	10237079835	6 VIAL, SINGLE-DOSE in 1 PACKAGE (10237-798-35) / 3.5 mL in 1 VIAL, SINGLE-DOSE	2021-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orajel Cold Sore Touch Free - Single Dose	Church & Dwight Co., Inc.	2026-05-13	HUMAN OTC DRUG LABEL	6