Menthol
- Product NDC
- 68599-0464
- 11-digit product format
- 685990464
- Labeler code
- 68599
- Product ID
- 68599-0464_24241327-4250-104a-e063-6294a90a41e7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cough Suppressant
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- McKesson
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-01-29
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- .7 g/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 68599-0464-9 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 68599-0464-9 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 68599-0464-9 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 68599-0464-9 | E | Excluded after deficient or non-compliant submission was not corrected | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | Y | Unknown FDA exclusion code: Y | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68599-0464-9 | Y | Unknown FDA exclusion code: Y | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | Y | Unknown FDA exclusion code: Y | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68599-0464-9 | Y | Unknown FDA exclusion code: Y | 9bebd1f3094a… | 5416666fcb17… |
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
- Menthol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | .7 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9d4def70-480f-f2fa-e053-2995a90a9877 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68599-0464-9 | 2022-10-24 | C162847 | 48780-1 | d6a99b39-4d89-a426-e053-dadaa90af4c2 | Menthol Eucalyptus |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-0464-9 | Menthol | 0.7 g in 1 JAR | LOZENGE | 0.7 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68599-0464 | MENTHOL (COUGH SUPPRESSANT) LOZENGE [MCKESSON] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241012_9d4def70-480f-f2fa-e053-2995a90a9877.zip |
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 |
|---|---|---|---|---|---|---|
| Cherry Cough Drop | MENTHOL | Safeway Inc. | 4a52c0c2-8659-2819-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| Signature Care Cherry Cough Drops | MENTHOL | Safeway | a733e905-af15-d3ea-e053-2a95a90aa7c3 | 2025-12-20 | Warnings | M012 |
| Signature Care Honey Lemon Cough Drops | MENTHOL | Safeway | a742449f-c76b-2b91-e053-2a95a90ae4d2 | 2025-12-20 | Warnings | M012 |
| Cherry Sore Throat Lozenge | BENZOCAINE | TopCo | 60b876e7-c642-5ce8-e053-2a91aa0abd6e | 2025-12-20 | Warnings | M012 |
| menthol cough drops | MENTHOL | Topco Associates | 366cc6b1-beff-29d2-e054-00144ff88e88 | 2025-12-20 | Warnings | M012 |
| cherry cough drops | MENTHOL | TopCo Associates | 3fef2117-7311-1e66-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Topco Associates | 3ff1bf05-e407-3b67-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| sugar free menthol cough drops | MENTHOL | Topco Associates | 36727f0c-d6d2-28a3-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| sugar free honey lemon cough drops | MENTHOL | Topco Associates | 36824bee-607e-7095-e054-00144ff8d46c | 2025-12-20 | Warnings | M012 |
| Mixed Berry Sore Throat Lozenges | BENZOCAINE | Topco Associates | 7a00c771-9231-e877-e053-2a91aa0ac96e | 2025-12-20 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | NUVICARE LLC | e25b440e-f389-443f-b333-c66ad1747158 | 2025-12-19 | Warnings | M012 |
| Cold and Flu severe | ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 | 2025-12-19 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | a7d2eaee-484e-43aa-8ae3-0e050219383f | 2025-12-19 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Publix | 66d8e5f7-9766-57f3-e053-2991aa0a7e17 | 2025-12-19 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Publix | 66e89fa3-ee09-1d16-e053-2a91aa0ae17c | 2025-12-19 | Warnings | M012 |
| Poly-Vent DM | DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 739329ae-0b62-4eab-a07d-867b5d3d61e0 | 2025-12-19 | Warnings | M012 |
| Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | ARMY AND AIR FORCE EXCHANGE SERVICE | 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 | 2025-12-19 | Warnings | M012 |
| DayTime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 04f9134e-1311-4843-90db-9244b9e61e1d | 2025-12-19 | Warnings | M012 |
| Nighttime Cold/Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 029e6215-b72d-4fd0-8918-db1abcc4490a | 2025-12-19 | Warnings | M012 |
| DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 5f680f37-b3db-450f-b8ca-f9e31a04dc04 | 2025-12-19 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68599-0464-9 | 68599046409 | .7 g in 1 JAR (68599-0464-9) | 2020-01-29 | 0000-00-00 | No | No | Current |