Orajel for Codl Sores Relief and Concealer

Product NDC: 10237-726
11-digit product format: 102370726
Labeler code: 10237
Product ID: 10237-726_ca4b753c-3809-41ac-8a88-eb295743dda0
Type: HUMAN OTC DRUG
Nonproprietary name: Allantoin Benzocaine Camphor
Dosage form: CREAM
Route: TOPICAL
Labeler: Church & Dwight Co., Inc.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-07-19
Marketing end: 0000-00-00
Substance: BENZOCAINE; CAMPHOR (NATURAL); ALLANTOIN; DIMETHICONE; MENTHOL; PETROLATUM
Active strength: 200 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10237-726		D	Discontinued by firm		2026-10-05
excluded package	package	10237-726	10237-726-05	D	Discontinued by firm		2026-10-05

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10237-726-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10237-726-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10237-726-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10237-726-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10237-726-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10237-726-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10237-726-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10237-726-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10237-726-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-726-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10237-726-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10237-726-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10237-726-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALLANTOIN	ACTIVE INGREDIENT	344S277G0Z	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
ALLANTOIN	ACTIVE MOIETY	344S277G0Z	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
IRON	INACTIVE INGREDIENT	E1UOL152H7	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
PRUNELLA VULGARIS	INACTIVE INGREDIENT	ID3IB81B1C	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ORAJEL FOR CODL SORES RELIEF AND CONCEALER (ALLANTOIN BENZOCAINE CAMPHOR) CREAM [CHURCH & DWIGHT CO., INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Church & Dwight Co., Inc. \| Direct Merchantdising Inc.	2010-07-19	HUMAN OTC DRUG LABEL	1

Orajel for Codl Sores Relief and Concealer

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#