Cepacol

Product NDC
63824-781
11-digit product format
638240781
Labeler code
63824
Product ID
63824-781_09b10616-eee1-43b7-a95d-3bef52b69143
Type
HUMAN OTC DRUG
Nonproprietary name
Dyclonine Hydrochloride and Glycerin
Dosage form
LIQUID
Route
ORAL
Labeler
RB Health (US) LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-20
Marketing end
0000-00-00
Substance
DYCLONINE HYDROCHLORIDE; GLYCERIN
Active strength
0 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct63824-781DDiscontinued by firm2026-08-11
excluded packagepackage63824-78163824-781-74DDiscontinued by firm2026-08-11

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 · 28 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued 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 packagepackage63824-781-74DDiscontinued by firm367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63824-781-74IInactivated 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 packagepackage63824-781-74IInactivated 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 packagepackage63824-781-74IInactivated by FDAbd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-781-742023-09-27C16284748780-1d6a99b39-eaf7-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT SPRAY
63824-781-742022-01-28C16284748780-1d6a99b39-eaf7-a426-e053-dadaa90af4c2Cēpacol ® SORE THROAT SPRAY

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dyclonine HydrochlorideACTIVE INGREDIENTZEC193879QCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
GlycerinACTIVE INGREDIENTPDC6A3C0OXCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
DyclonineACTIVE MOIETY078A24Q30OCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
GlycerinACTIVE MOIETYPDC6A3C0OXCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
cetylpyridinium chlorideINACTIVE INGREDIENTD9OM4SK49PCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
D&C red No. 33INACTIVE INGREDIENT9DBA0SBB0LCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8CEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
mentholINACTIVE INGREDIENTL7T10EIP3ACEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
poloxamer 338INACTIVE INGREDIENTF75JV2T505CEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4CEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74CEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
sorbitolINACTIVE INGREDIENT506T60A25RCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1
waterINACTIVE INGREDIENT059QF0KO0RCEPACOL SORE THROAT (DYCLONINE HYDROCHLORIDE AND GLYCERIN) LIQUID [RECKITT BENCKISER LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-781-7463824078174118 mL in 1 BOTTLE (63824-781-74) 118 ml2011-05-200000-00-00NoNoCurrent