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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
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 table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	.7 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9d4def70-480f-f2fa-e053-2995a90a9877	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
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 table
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 table
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.

Matched openFDA labels page 156 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SanaTos X Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Pharmadel LLC	1fc1408c-c540-39ab-e063-6394a90aa477	2024-08-15	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	489645ad-d7da-5f52-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6c949602-e0c8-40ce-8fb3-5147f406fa04	2024-08-14	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	3dbdf020-ca17-1197-e054-00144ff8d46c	2024-08-13	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	445e49a2-6ed0-434c-aaea-3ce14bc7df59	2024-08-12	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	d49b42ad-0ae0-48c9-adba-5fc2ced97764	2024-08-12	Warnings	Exact identifier application number: M012
RYMED	DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	c1d6e914-74cc-4cdf-9587-7eaaa4a386e5	2024-08-12	Warnings	Exact identifier application number: M012
WesTussin DM NF	WESTUSSIN DM NF	Westminster Pharmaceuticals, LLC	4e0f9f97-a31c-41ac-9d6c-d81efd20fcef	2024-08-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	2f2a2864-af11-4240-bdad-a54aca58d01b	2024-08-07	Warnings	Exact identifier application number: M012
Cold plus Flu Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0199aea2-a9c1-4c9d-8786-28b9dadc832e	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	32d1ce6e-2617-4b50-a9e6-2e1941465dff	2024-08-07	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	07362db5-a372-4463-af8b-06e8783ca865	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	1fb11d90-48bf-4baa-9b3a-5d64d81e3a06	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	574774b2-9813-4799-9cd4-27e296dd8584	2024-08-07	Warnings	Exact identifier application number: M012
Cold Max Day and NIght	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a92bcefb-ba29-4b3f-a60b-b4476ca8cf04	2024-08-07	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	778f1f5a-fd04-456f-90d0-998b93e774a5	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	990f3232-bc75-45cf-8a50-cd7861d83f98	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0f5f25c6-7389-4285-b8d5-463cb7b6fcc4	2024-08-07	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Care One (Retail Business Services, LLC.)	a9a5b39d-b4c8-414e-8fe7-4c0601f75197	2024-08-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	2024-08-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

Packages#

Package NDC, 11-digit format, Description table
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Menthol Eucalyptus	McKesson \| Pharmaloz Manufacturing, Inc. \| Prestige Packaging	2024-10-10	HUMAN OTC DRUG LABEL	8