Cepacol
- Product NDC
- 63824-713
- 11-digit product format
- 638240713
- Labeler code
- 63824
- Product ID
- 63824-713_51a69c7a-3f79-01bc-e063-6394a90adcaa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine and Menthol
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-15
- Substance
- BENZOCAINE; MENTHOL, UNSPECIFIED FORM
- Active strength
- 15; 3.6 mg/1; mg/1
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63824-713 | 63824-713-04 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63824-713 | 63824-713-94 | D | Discontinued by firm | 2026-10-05 |
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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 63824-713-94 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 63824-713-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 63824-713-94 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 63824-713-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 63824-713-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 63824-713-94 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 63824-713-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 63824-713-94 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 63824-713-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 63824-713-94 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 63824-713-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 63824-713-94 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 63824-713-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 63824-713-94 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 63824-713-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 63824-713-94 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 63824-713-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 63824-713-94 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 63824-713-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 63824-713-94 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 63824-713-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 63824-713-94 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 63824-713-04 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 63824-713-94 | 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 cherry
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 15 mg/1 |
| MENTHOL, UNSPECIFIED FORM | 3.6 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-713-04 | CepacolExtra Strength Sore Throat cherry | 4 in 1 BLISTER PACK | LOZENGE | 4 | 11 | |
| 63824-713-04 | CepacolExtra Strength Sore Throat cherry | 1 in 1 CARTON | LOZENGE | 1 | 11 | |
| 63824-713-16 | CepacolExtra Strength Sore Throat cherry | 8 in 1 BLISTER PACK | LOZENGE | 8 | 11 | |
| 63824-713-16 | CepacolExtra Strength Sore Throat cherry | 2 in 1 CARTON | LOZENGE | 2 | 11 | |
| 63824-713-94 | CepacolExtra Strength Sore Throat cherry | 1 in 1 CARTON | LOZENGE | 1 | 11 | |
| 63824-713-94 | CepacolExtra Strength Sore Throat cherry | 4 in 1 BLISTER PACK | LOZENGE | 4 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-713-16 | EA - Each | 63824-713 | 01e4f83d-bb43-40b3-a104-54915296c781 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CrystLCare Regeneration Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | GreenMark Biomedical Inc. | 4f86d0a0-d73e-5605-e063-6394a90adb38 | 2026-09-14 | Warnings | M022 |
| Opalescence Whitening Sensitivity Relief | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 44e94663-895b-67da-e063-6394a90a5fe6 | 2026-09-09 | Warnings | M022 |
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | M022 |
| Opal by Opalescence Sensitivity | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 5ffc0d14-0290-47bb-90e5-90a25a5acc28 | 2026-09-09 | Warnings | M022 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | M022 |
| SORE THROAT | PHENOL | Raritan Pharmaceuticals Inc | 43ce374a-824c-4034-bf04-c351b4d8015b | 2026-09-08 | Warnings | M022 |
| Colgate Optic White Stain Fighter Sens Relief | SODIUM FLUORIDE | Colgate-Palmolive Company | 6ec2fff7-df44-4302-be2d-97946c6cd66a | 2026-09-08 | Warnings | M022 |
| DRx Choice Sore Throat Menthol Flavor | PHENOL | RARITAN PHARMACEUTICALS INC | e3269b12-5c05-45a6-81f2-65d9f016c3aa | 2026-09-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 0733015b-e81a-4a62-82ad-dacaf3f163cb | 2026-09-02 | Warnings | M022 |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT | HEXYLRESORCINOL | Reckitt Benckiser LLC | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | M022 |
| LUDENS SUGAR FREE WILD CHERRY THROAT | PECTIN | Prestige Brands Holdings, Inc. | 274fc80c-e5b2-41c7-a119-287d6e8a2258 | 2026-08-28 | Warnings | M022 |
| Medline Peroxi Fresh Mouthwash | HYDROGEN PEROXIDE | Medline Industries, LP | ec7a9240-6c66-4471-b8b6-776e08a14fbc | 2026-08-27 | Warnings | M022 |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-08-25 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 824574 | benzocaine 15 MG / menthol 3.6 MG Oral Lozenge | PSN | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
| 1235477 | Cepacol Sore Throat 15 MG / 3.6 MG Oral Lozenge | PSN | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
| 1235477 | benzocaine 15 MG / menthol 3.6 MG Oral Lozenge [Cepacol Sore Throat Pain Relief] | SBD | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
| 824574 | benzocaine 15 MG / menthol 3.6 MG Oral Lozenge | SCD | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
| 1235477 | Cepacol Sore Throat Pain Relief 15/3.6 (benzocaine / menthol) Oral Lozenge | SY | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
| 1235477 | Cepacol Sore Throat Pain Relief 15/3.6 Oral Lozenge | SY | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-713-04 | 63824071304 | 1 BLISTER PACK in 1 CARTON (63824-713-04) > 4 LOZENGE in 1 BLISTER PACK | 1 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |
| 63824-713-16 | 63824071316 | 2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK | 2 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |
| 63824-713-94 | 63824071394 | 1 BLISTER PACK in 1 CARTON (63824-713-94) > 4 LOZENGE in 1 BLISTER PACK | 1 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |