Home NDC 63824-768-16 Cepacol
Product NDC 63824-768
Requested package NDC 63824-768-16
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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