Cepacol

Product NDC: 63824-744
11-digit product format: 638240744
Labeler code: 63824
Product ID: 63824-744_51b5d087-def6-54b3-e063-6294a90ac9ad
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: LOZENGE
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-05-05
Substance: DEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE
Active strength: 5; 7.5 mg/1; mg/1
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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	63824-744	63824-744-36	D	Discontinued by firm		2026-10-20
excluded package	package	63824-744	63824-744-94	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	63824-744-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	63824-744-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	63824-744-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	63824-744-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	63824-744-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	63824-744-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	63824-744-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	63824-744-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	63824-744-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	63824-744-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	63824-744-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	63824-744-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	63824-744-94	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	63824-744-36	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	63824-744-94	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	63824-744-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	63824-744-94	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	63824-744-36	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	63824-744-94	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	63824-744-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	63824-744-94	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	63824-744-36	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	63824-744-94	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	63824-744-36	`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 and Cough
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/1
BENZOCAINE	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1039251	Internal RxNorm lookup
1039255	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
c0cc32db-90f0-4106-8538-89821083ece1	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
63824-744-16	CepacolExtra Strength Sore Throat and Cough	8 in 1 BLISTER PACK	LOZENGE	8	14
63824-744-16	CepacolExtra Strength Sore Throat and Cough	2 in 1 CARTON	LOZENGE	2	14
63824-744-36	CepacolExtra Strength Sore Throat and Cough	3 in 1 CARTON	LOZENGE	3	14
63824-744-36	CepacolExtra Strength Sore Throat and Cough	12 in 1 BLISTER PACK	LOZENGE	12	14
63824-744-94	CepacolExtra Strength Sore Throat and Cough	4 in 1 BLISTER PACK	LOZENGE	4	14
63824-744-94	CepacolExtra Strength Sore Throat and Cough	1 in 1 CARTON	LOZENGE	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-744-16	EA - Each	63824-744	7cd08d15-6f23-4040-a102-e5213cd34025	1	2019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
isomalt	INACTIVE INGREDIENT	S870P55O2W	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
maltitol	INACTIVE INGREDIENT	D65DG142WK	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2
water	INACTIVE INGREDIENT	059QF0KO0R	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-744	CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC]	10	Current NDC, Legacy NDC, 6 package rows	20250323_c0cc32db-90f0-4106-8538-89821083ece1.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 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	14c56f3d-67fd-45ef-a16b-f27604722883	2026-05-12	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	51a4195b-8776-964c-e063-6294a90aa075	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba3548e-85e7-b4a6-e063-6394a90af84d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe7eeb71-e219-4c84-ac06-98c3a40b14dc	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6f8241d7-0f30-40b3-926b-861c57079f1d	2026-05-12	Warnings	Exact identifier application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51a45db8-2bee-6fd0-e063-6394a90ab587	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	19da539e-7b57-41d7-aad5-fc89a6705e20	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	182222b5-a852-4dbe-b05f-a41d89806021	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8a790eeb-7d7d-4a94-9103-6ed09c04d596	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	dbdafbb4-f3c9-4042-b867-db4d06dc3d61	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d03ef2fd-1a08-42c0-b69d-fd4e4285ccd3	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	29571047-4c4b-44ca-8726-57c28308e8cf	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift Sinus	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	75c6b92f-219f-4740-bb72-c02a927a21ff	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	c746953f-4b7d-4e2a-9b85-96bd6901f517	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	cea08797-1d53-4434-be1a-144f2ded5f9d	2026-05-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ef9d5de-e99e-4398-bf97-c7bef94498fa	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a401eb92-60b6-427d-a677-29371a3150be	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ff4c4ea-7628-4d2b-a6e9-d994c25baef4	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7c18e95-8d7b-4550-9a20-fc704a114adb	2026-05-12	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039255	Cepacol Sore Throat Plus Cough 7.5 MG / 5 MG Oral Lozenge	PSN	c0cc32db-90f0-4106-8538-89821083ece1	14
1039251	dextromethorphan HBr 5 MG / benzocaine 7.5 MG Oral Lozenge	PSN	c0cc32db-90f0-4106-8538-89821083ece1	14
1039255	benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge [Cepacol Sore Throat Plus Cough]	SBD	c0cc32db-90f0-4106-8538-89821083ece1	14
1039251	benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG Oral Lozenge	SCD	c0cc32db-90f0-4106-8538-89821083ece1	14
1039255	Cepacol Sore Throat Plus Cough (benzocaine 7.5 MG / dextromethorphan hydrobromide 5 MG) Oral Lozenge	SY	c0cc32db-90f0-4106-8538-89821083ece1	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-744-16	63824074416	2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK	2 blister pack	2014-05-05	0000-00-00	No	No	Current
63824-744-36	63824074436	3 BLISTER PACK in 1 CARTON (63824-744-36) > 12 LOZENGE in 1 BLISTER PACK	3 blister pack	2019-05-01	0000-00-00	No	No	Current
63824-744-94	63824074494	1 BLISTER PACK in 1 CARTON (63824-744-94) > 4 LOZENGE in 1 BLISTER PACK	1 blister pack	2014-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cēpacol ® Extra Strength Sore Throat & Cough	Reckitt Benckiser LLC	2026-05-13	HUMAN OTC DRUG LABEL	14