Leader Cough Drops Vanilla Honey

Product NDC: 70000-0692
11-digit product format: 700000692
Labeler code: 70000
Product ID: 70000-0692_468b5336-403f-9f0d-e063-6294a90aece4
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: LOZENGE
Route: ORAL
Labeler: Cardinal Health 110, LLC. DBA Leader
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-10
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 2.5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Leader Cough Drops Vanilla Honey
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	2.5 mg/1

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616344	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0692-1	Leader Cough Drops Vanilla Honey	30 in 1 BAG	LOZENGE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0692	LEADER COUGH DROPS VANILLA HONEY (MENTHOL) LOZENGE [CARDINAL HEALTH 110, LLC. DBA LEADER]	2	Current NDC, 1 package rows	20241109_1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2.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 130 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Daytime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Company	e428dd83-c538-2a92-e053-2a95a90a0e16	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Nighttime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Company	e46291c7-6f4d-46a2-e053-2a95a90a80a1	2024-12-13	Warnings	Exact identifier application number: M012
Foster and Thrive Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	7eaba464-5cdb-4bd4-b272-38fa108658d5	2024-12-13	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride 25mg	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Strive Pharmaceuticals Inc	b440eb2e-4de9-2b65-e053-2995a90abda8	2024-12-11	Warnings	Exact identifier application number: M012
Meijer Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	6933ca9d-a32d-d856-e053-2a91aa0a408e	2024-12-10	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	826b5c0d-7a75-bbf0-e053-2a91aa0aebd6	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	09141018-37ba-4c93-9051-1ed129c448c1	2024-12-10	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola USA Inc.	6ac9d95b-f6b9-4515-b126-697f8f839612	2024-12-10	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola USA Inc.	989d1529-2875-47bf-81df-65494d62be7a	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	82813342-2be2-4731-ae90-dbd5eed667a9	2024-12-10	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	b640a5d2-a7fe-486d-a65f-e7c993f950d6	2024-12-10	Warnings	Exact identifier application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat Drops	MENTHOL	Ricola USA Inc.	c3f3c062-55e5-43c1-a016-ee47a7b388a5	2024-12-10	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola USA Inc.	ee4733b5-6e5a-438a-97da-110f3ef6c809	2024-12-10	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola USA Inc.	f62fcc38-2d43-40b3-841f-c8eea9ebd1e1	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	8a6db093-7e52-443f-8dd6-94867606fef8	2024-12-10	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola USA Inc.	5885343e-4a6e-44f7-87a4-d52599156197	2024-12-10	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola USA Inc.	0baf383c-886d-47ca-8a6d-221298c79446	2024-12-10	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Best Choice (Valu Merchandisers Company)	539b8972-2a46-468e-ad27-6672d746feb7	2024-12-10	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616344	menthol 2.5 MG Oral Lozenge	PSN	1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2	3
616344	menthol 2.5 MG Oral Lozenge	SCD	1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70000-0692-1	70000069201	30 LOZENGE in 1 BAG (70000-0692-1)	30 lozenge	2024-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEADER TM Cough Drops Vanilla Honey Flavor	Cardinal Health 110, LLC. DBA Leader \| Medical Group Care LLC	2025-12-22	HUMAN OTC DRUG LABEL	3