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 137 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Exact identifier application number: M017
Nova Natura Topical Analgesic	CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE	SEYITLER KIMYA SANAYI ANONIM SIRKETI	abf00f73-f0b1-439e-85aa-bbce8a1ec920	2024-02-06	Warnings	Exact identifier application number: M017
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Exact identifier application number: M017
Pain Relieving Petro Carbo	PHENOL	J.R. Watkins, LLC.	050cf17d-3be7-45b9-8524-ad82af309a0e	2024-02-06	Warnings	Exact identifier application number: M017
White Cream	CAMPHOR (NATURAL) AND TURPENTINE OIL	J.R. Watkins, LLC.	e4de0734-59d5-478c-86ea-66fc2ba003e7	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	80118260-9c88-402d-9a90-ecfe62b4b54f	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	df512ce6-ce1b-434d-9571-fb2e1d76e1d0	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL	Safetec of America, Inc.	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2024-02-05	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	79e3b0e7-4ba5-4b9d-a980-5b6f18dba802	2024-02-04	Warnings	Exact identifier application number: M017
HAV EZ Penetrating Pain Relief	MENTHOL	PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC	70006efc-9cc8-4490-b28c-fcb23b1737c4	2024-02-01	Warnings	Exact identifier application number: M017
Rugby Capsaicin External Analgesic	CAPSAICIN	Proficient Rx LP	7c733a30-5002-49e7-a6bd-7737a1d2461e	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	ccb62898-b614-45b9-95ea-23e5e31893a8	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	Proficient Rx LP	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	c57d5f8e-5934-4cbb-999a-cdd55e5b105f	2024-02-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Proficient Rx LP	47e9fe84-bd0c-40ea-85de-e950bcacc557	2024-02-01	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