DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC

Product NDC: 63667-603
11-digit product format: 636670603
Labeler code: 63667
Product ID: 63667-603_fdd9887a-22ba-4242-9c08-77f202dc6973
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LOZENGE
Route: ORAL
Labeler: Ricola USA Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-01
Substance: MENTHOL
Active strength: 8.3 mg/1
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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63667-603-19	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63667-603-26	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63667-603-19	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63667-603-26	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63667-603-19	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63667-603-26	`bd6a592717d7…`	`303034d00443…`

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: DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	8.3 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
1424614	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
db2ab9be-507d-4768-9d00-188f751b7726	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63667-603-19	2023-01-18	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-26	2023-01-18	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-19	2022-01-28	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-26	2022-01-28	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-19	2020-02-10	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-26	2020-02-10	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-19	2020-01-31	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC
63667-603-26	2020-01-31	DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63667-603-19	DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	19 in 1 BAG	LOZENGE	19		4
63667-603-26	DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	26 in 1 BAG	LOZENGE	26		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63667-603	DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC (MENTHOL) LOZENGE [RICOLA USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20241211_db2ab9be-507d-4768-9d00-188f751b7726.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 60 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e07931fc-f753-1aeb-e053-2a95a90ada3f	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc60af2f-83cb-99ea-e053-6394a90a0b3b	2026-01-08	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e17eb929-209d-a2d1-e053-2a95a90a4cf3	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz	ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c1fae6c7-bbac-1320-e053-2a95a90aac5a	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	f4c60ca1-ba59-4a92-84a5-6ba65faa56ab	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Day Severe Cold Plus Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	cec51eab-cce3-4965-a14e-a46d953050c4	2026-01-08	Warnings	Exact identifier application number: M012
VanaCof 2	CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE	GM Pharmaceuticals, INC	0c7c6756-abb2-c10c-e063-6394a90a9863	2026-01-08	Warnings	Exact identifier application number: M012
VANACOF XP Cough / Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	GM Pharmaceuticals, INC	0b3a8cc1-a49f-e1e5-e063-6394a90a1c06	2026-01-08	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	INVAHEALTH INC	e4e4004f-77e3-569d-e053-2a95a90a73fe	2026-01-08	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	868ac65a-63e2-46ac-b87d-66b289086756	2026-01-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	0324195f-506d-4747-990e-ad44e2a117d9	2026-01-07	Warnings	Exact identifier application number: M012
Sambrosa Night	DOXYLAMINE SUCCINATE	Sambrosa Care, Inc.	acdc8740-6231-d1e8-e053-2995a90a3b8d	2026-01-07	Warnings	Exact identifier application number: M012
VAPOREX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	DLC Laboratories, Inc.	971943b1-4199-4f75-9d2d-61242d346b5f	2026-01-07	Warnings	Exact identifier application number: M012
BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DLC Laboratories, Inc.	2e612c62-9bbb-45f2-a253-aa2bfaeaac70	2026-01-07	Warnings	Exact identifier application number: M012
Earths Care Chest Rub	CAMPHOR, EUCALYPTUS OI, MENTHOL	DLC Laboratories, Inc	2424f5d5-1772-96f1-e063-6294a90a89ee	2026-01-07	Warnings	Exact identifier application number: M012
Bactimicina Vapor Rub	VAPOR RUB	DLC Laboratories, Inc.	176b617a-faf6-7893-e063-6294a90a046b	2026-01-07	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, PHENYLEPHRINE HCL	Family Dollar Services Inc	0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2	2026-01-07	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	b225e897-5728-4519-b727-c0f361c75976	2026-01-07	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	80b218f7-66bb-4e15-a0dc-ec9b6af1b056	2026-01-07	Warnings	Exact identifier application number: M012
tussin cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	13618054-d0c5-4190-b626-e7e91b855738	2026-01-06	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1424614	menthol 8.3 MG Oral Lozenge	PSN	db2ab9be-507d-4768-9d00-188f751b7726	4
1424614	menthol 8.3 MG Oral Lozenge	SCD	db2ab9be-507d-4768-9d00-188f751b7726	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63667-603-19	63667060319	19 LOZENGE in 1 BAG (63667-603-19)	19 lozenge	2016-01-01	0000-00-00	No	No	Current
63667-603-26	63667060326	26 LOZENGE in 1 BAG (63667-603-26)	26 lozenge	2016-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUAL ACTION GLACIER MINT SUPPRESSANT ORAL ANESTHETIC	Ricola USA Inc. \| Ricola Ag	2024-12-10	HUMAN OTC DRUG LABEL	4