Home NDC 63824-768 Cepacol
Product NDC 63824-768
11-digit product format 638240768
Labeler code 63824
Product ID 63824-768_05eb3c99-8580-4f4d-9174-5c49fe3f1d50
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and Menthol, Unspecified Form
Dosage form LOZENGE
Route ORAL
Labeler RB Health (US) LLC
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-07-15
Marketing end 0000-00-00
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 15 mg/1; mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63824-768-16 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63824-768-16 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63824-768-16 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63824-768-16 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63824-768-16 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63824-768-16 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63824-768-16 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63824-768-16 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63824-768-16 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63824-768-16 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63824-768-16 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63824-768-16 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Benzocaine ACTIVE INGREDIENT U3RSY48JW5 CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 Menthol, Unspecified Form ACTIVE INGREDIENT L7T10EIP3A CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 Benzocaine ACTIVE MOIETY U3RSY48JW5 CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 Menthol, Unspecified Form ACTIVE MOIETY L7T10EIP3A CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 isomalt INACTIVE INGREDIENT S870P55O2W CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 maltitol INACTIVE INGREDIENT D65DG142WK CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 sodium bicarbonate INACTIVE INGREDIENT 8MDF5V39QO CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2 water INACTIVE INGREDIENT 059QF0KO0R CEPACOL EXTRA STRENGTH SORE THROAT TANGERINE (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) LOZENGE [RECKITT BENCKISER LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-768-16 63824076816 2 BLISTER PACK in 1 CARTON (63824-768-16) > 8 LOZENGE in 1 BLISTER PACK 2 blister pack 2015-07-15 0000-00-00 No No Current