Sugar Free Menthol Cough Drops

Product NDC
67091-303
11-digit product format
670910303
Labeler code
67091
Product ID
67091-303_46a60e99-524c-fda3-e063-6394a90a1711
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Winco Foods
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-19
Substance
MENTHOL
Active strength
5.8 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct67091-303DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67091-30367091-303-25DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
Sugar Free Menthol Cough Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476973Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3788e8b6-ab9e-1513-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-303-25Sugar Free Menthol Cough Drops25 in 1 BAGLOZENGE258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-303SUGAR FREE MENTHOL COUGH DROPS (MENTHOL) LOZENGE [WINCO FOODS]7Current NDC, Legacy NDC, 1 package rows20240724_3788e8b6-ab9e-1513-e054-00144ff88e88.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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSN3788e8b6-ab9e-1513-e054-00144ff88e888
476973menthol 5.8 MG Oral LozengeSCD3788e8b6-ab9e-1513-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-303-256709103032525 LOZENGE in 1 BAG (67091-303-25) 25 lozenge2014-08-190000-00-00NoNoCurrent