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 |
|---|---|---|---|---|---|---|
| COLD AND FLU NIGHTTIME SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3 | 2024-09-25 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8f3317f6-4ae8-474b-93c3-25e256519cb8 | 2024-09-25 | Warnings | M012 |
| berkley and jensen tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | b2de91c9-6af0-4881-8d2d-a69d90c8dfcd | 2024-09-24 | Warnings | M012 |
| Tussin DM Cough and Chest Non Drowsy | DEXTROMETHORPHAN HBR, GUAIFENESIN | WinCo Foods, LLC | 13eb459c-3075-4038-8062-9ee7175b2ab9 | 2024-09-24 | Warnings | M012 |
| equaline nasal decongestant non drowsy maximum strength | PSEUDOEPHEDRINE HCL | United Natural Foods, Inc. dba UNFI | 8897580a-709a-4643-8264-ad003d90cbff | 2024-09-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Dabur India Limited | 22916978-303d-e62a-e063-6394a90a2100 | 2024-09-20 | Warnings | M012 |
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 5791c1c7-f614-4940-a45a-6291742e1e22 | 2024-09-17 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 2affd44d-2125-4a1f-919c-c082e7644ea8 | 2024-09-17 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Advanced Rx LLC | fa1b60b1-49cb-1211-e053-6394a90a0a46 | 2024-09-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 8db7df1c-46b5-49bd-9002-50b12d58001a | 2024-09-13 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1bdd7f8a-93ce-5309-e063-6294a90a91f0 | 2024-09-12 | 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 |