Cepacol

Product NDC: 63824-732
11-digit product format: 638240732
Labeler code: 63824
Product ID: 63824-732_51a73861-dad4-e880-e063-6294a90a9190
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; 2.6 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

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 honey lemon
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	15 mg/1
MENTHOL, UNSPECIFIED FORM	2.6 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
858664	Internal RxNorm lookup
1235472	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
d771095b-7de3-48f3-a125-8bc76e7d1778	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	Strength	SPL version
63824-732-16	CepacolExtra Strength Sore Throat honey lemon	8 in 1 BLISTER PACK	LOZENGE	8		12
63824-732-16	CepacolExtra Strength Sore Throat honey lemon	2 in 1 CARTON	LOZENGE	2		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-732-16	EA - Each	63824-732	7758e732-5bdc-4055-a3f5-57cf36bc3e51	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
isomalt	INACTIVE INGREDIENT	S870P55O2W	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
maltitol	INACTIVE INGREDIENT	D65DG142WK	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RECKITT BENCKISER LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-732	CEPACOL EXTRA STRENGTH SORE THROAT HONEY LEMON (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250330_d771095b-7de3-48f3-a125-8bc76e7d1778.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	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
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	PSN	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat 15 MG / 2.6 MG Oral Lozenge	PSN	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	d771095b-7de3-48f3-a125-8bc76e7d1778	12
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	SCD	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral Lozenge	SY	d771095b-7de3-48f3-a125-8bc76e7d1778	12
1235472	Cepacol Sore Throat Pain Relief 15/2.6 Oral Lozenge	SY	d771095b-7de3-48f3-a125-8bc76e7d1778	12
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	PSN	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat 15 MG / 2.6 MG Oral Lozenge	PSN	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief]	SBD	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
858664	benzocaine 15 MG / menthol 2.6 MG Oral Lozenge	SCD	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat Pain Relief 15/2.6 (benzocaine / menthol) Oral Lozenge	SY	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7
1235472	Cepacol Sore Throat Pain Relief 15/2.6 Oral Lozenge	SY	08160ced-e19b-443e-ab16-0d3e4ae8a8ab	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-732-16	63824073216	2 BLISTER PACK in 1 CARTON (63824-732-16) / 8 LOZENGE in 1 BLISTER PACK	2 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 honey lemon	ATLANTIC BIOLOGICALS CORP.	2026-10-09	HUMAN OTC DRUG LABEL	9
Cēpacol ® Extra Strength Sore Throat honey lemon	Reckitt Benckiser LLC	2026-05-12	HUMAN OTC DRUG LABEL	12