Orajel Instant Pain Relief

Product NDC: 10237-747
11-digit product format: 102370747
Labeler code: 10237
Product ID: 10237-747_4ce932f7-46fe-2caf-e054-00144ff88e88
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine 20%, Menthol, Benzalkonium Chloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Church Dwight Co., Inc.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-02-27
Marketing end: 0000-00-00
Substance: BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL
Active strength: 200 mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10237-747		D	Discontinued by firm	2026-10-05
excluded product	product	10237-747		D	Discontinued by firm	2026-10-05
excluded product	product	10237-747		D	Discontinued by firm	2026-10-05
excluded package	package	10237-747	10237-747-32	D	Discontinued by firm	2026-10-05
excluded package	package	10237-747	10237-747-25	D	Discontinued by firm	2026-10-05
excluded package	package	10237-747	10237-747-33	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 2 · 90 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
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	10237-747-32	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10237-747-25	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	10237-747-32	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10237-747-25	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
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	10237-747-32	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10237-747-25	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	10237-747-32	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10237-747-25	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
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	10237-747-32	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10237-747-25	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
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	10237-747-32	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10237-747-25	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
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	10237-747-32	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10237-747-25	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
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	10237-747-32	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10237-747-25	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10237-747-33	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 product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
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	10237-747-32	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10237-747-25	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10237-747-33	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
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 product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-747-32	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-747-25	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10237-747-33	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10237-747-32	2024-11-27	C162847	48780-1	9d75b9d0-da8c-f424-e053-dadaa90a57ce	Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED
10237-747-32	2020-01-31	C162847	48780-1	9d75b9d0-da8c-f424-e053-dadaa90a57ce	Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
PECTIN	INACTIVE INGREDIENT	89NA02M4RX	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
POLYETHYLENE GLYCOL 1000	INACTIVE INGREDIENT	U076Q6Q621	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) CREAM [CHURCH DWIGHT CO., INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ORAJEL INSTANT PAIN RELIEF SEVERE (BENZOCAINE 20%, MENTHOL, BENZALKONIUM CHLORIDE) 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
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED	Church Dwight Co., Inc.	2017-04-11	HUMAN OTC DRUG LABEL	5
Orajel SEVERE Toothache & Gum Relief Plus TRIPLE MEDICATED	Church Dwight Co., Inc.	2017-04-05	HUMAN OTC DRUG LABEL	3

Orajel Instant Pain Relief

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#