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 | 2026-08-17 | |
| excluded package | package | 63824-713 | 63824-713-94 | D | Discontinued by firm | 2026-08-17 |
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… |
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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Walgreens | fb93c7f6-e025-4cf2-9997-acfe9a0debdd | 2026-08-19 | Warnings | M022 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | M022 |
| Ludens Honey Licorice Throat Drops | MENTHOL | Prestige Brands Holdings, Inc. | 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac | 2026-08-19 | Warnings | M022 |
| Ludens Dual Relief | PECTIN AND MENTHOL | Prestige Brands Holdings, Inc. | d0213cb3-ec8e-40cc-82c9-694032f0490f | 2026-08-19 | Warnings | M022 |
| CVS Health Sore Throat Fast Relief Oral Anesthetic | PHENOL | CVS Pharmacy,Inc. | 4fb880db-2185-41ef-a5f9-8983a28d2c5b | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Cherry | PHENOL | CVS Pharmacy,Inc. | 887c68e0-ff44-4bad-b360-56fb99ed9c45 | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Menthol Flavor | PHENOL | CVS PHARMACY,INC. | 665be058-b965-4b78-80b0-dd8524180932 | 2026-08-17 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | 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 |