Cepacol

Product NDC
63824-743
11-digit product format
638240743
Labeler code
63824
Product ID
63824-743_ec46e06a-d90e-4053-ac9c-37a1a09f6aeb
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
LOZENGE
Route
ORAL
Labeler
Reckitt Benckiser LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-15
Marketing end
0000-00-00
Substance
BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
8 mg/1; mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63824-743DDiscontinued by firm2026-10-05
excluded packagepackage63824-74363824-743-16DDiscontinued by firm2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63824-743-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63824-743-16DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63824-743-16DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63824-743-16DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63824-743-16DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63824-743-16DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63824-743-16DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63824-743-16DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63824-743-16DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63824-743-16DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63824-743-16DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63824-743-16DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63824-743-16IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63824-743-16IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63824-743-16IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63824-743-16IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63824-743-16IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63824-743-16IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-743-16EA - Each63824-743cec5a9bf-68b4-474d-86c8-7d41212a644112014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
dextroseINACTIVE INGREDIENTIY9XDZ35W2CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDCEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOCEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
sucroseINACTIVE INGREDIENTC151H8M554CEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2
waterINACTIVE INGREDIENT059QF0KO0RCEPACOL EXTRA STRENGTH SORE THROAT MIXED BERRY (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RECKITT BENCKISER LLC]2