Cepacol

Product NDC: 63824-713
11-digit product format: 638240713
Labeler code: 63824
Product ID: 63824-713_51a69c7a-3f79-01bc-e063-6394a90adcaa
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine and Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-15
Substance: BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength: 15; 3.6 mg/1; mg/1
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

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 package	package	63824-713	63824-713-04	D	Discontinued by firm		2026-10-20
excluded package	package	63824-713	63824-713-94	D	Discontinued by firm		2026-10-20

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	63824-713-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	63824-713-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	63824-713-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	63824-713-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	63824-713-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	63824-713-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	63824-713-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	63824-713-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	63824-713-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	63824-713-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	63824-713-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	63824-713-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	63824-713-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	63824-713-94	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	63824-713-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	63824-713-94	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	63824-713-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	63824-713-94	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	63824-713-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	63824-713-94	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	63824-713-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	63824-713-94	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	63824-713-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	63824-713-94	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Cepacol
Brand name suffix: Extra Strength Sore Throat cherry
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	15 mg/1
MENTHOL, UNSPECIFIED FORM	3.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
824574	Internal RxNorm lookup
1235477	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
941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-713-04	CepacolExtra Strength Sore Throat cherry	4 in 1 BLISTER PACK	LOZENGE	4	11
63824-713-04	CepacolExtra Strength Sore Throat cherry	1 in 1 CARTON	LOZENGE	1	11
63824-713-16	CepacolExtra Strength Sore Throat cherry	8 in 1 BLISTER PACK	LOZENGE	8	11
63824-713-16	CepacolExtra Strength Sore Throat cherry	2 in 1 CARTON	LOZENGE	2	11
63824-713-94	CepacolExtra Strength Sore Throat cherry	1 in 1 CARTON	LOZENGE	1	11
63824-713-94	CepacolExtra Strength Sore Throat cherry	4 in 1 BLISTER PACK	LOZENGE	4	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-713-16	EA - Each	63824-713	01e4f83d-bb43-40b3-a104-54915296c781	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
Menthol, Unspecified Form	ACTIVE INGREDIENT	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
Menthol, Unspecified Form	ACTIVE MOIETY	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
isomalt	INACTIVE INGREDIENT	S870P55O2W	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
maltitol	INACTIVE INGREDIENT	D65DG142WK	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3
water	INACTIVE INGREDIENT	059QF0KO0R	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-713	CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC]	10	Current NDC, Legacy NDC, 6 package rows	20250330_941e36dd-d8d0-4e5c-8585-10e8f06bf8f0.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 2 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	Warnings	Exact identifier application number: M022
Ludens Watermelon Throat Drops	PECTIN	Prestige Brands Holdings, Inc.	adfb248a-96bb-4742-9df6-c47edccdd671	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	5965eb2a-1261-5258-e063-6294a90a7c2d	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	PSN	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11
1235477	Cepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge	PSN	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11
1235477	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11
824574	benzocaine 15 MG / menthol 3.6 MG Oral Lozenge	SCD	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11
1235477	Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge	SY	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11
1235477	Cepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge	SY	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-713-04	63824071304	1 BLISTER PACK in 1 CARTON (63824-713-04) > 4 LOZENGE in 1 BLISTER PACK	1 blister pack	2013-07-15	0000-00-00	No	No	Current
63824-713-16	63824071316	2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK	2 blister pack	2013-07-15	0000-00-00	No	No	Current
63824-713-94	63824071394	1 BLISTER PACK in 1 CARTON (63824-713-94) > 4 LOZENGE in 1 BLISTER PACK	1 blister pack	2013-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cēpacol ® Extra Strength Sore Throat cherry	Reckitt Benckiser LLC	2026-05-12	HUMAN OTC DRUG LABEL	11