Sugar Free Cough Drops

Product NDC
51316-989
11-digit product format
513160989
Labeler code
51316
Product ID
51316-989_387cc56d-9ca6-2e43-e063-6394a90a7347
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PASTILLE
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-26
Substance
MENTHOL
Active strength
5.8 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
Sugar Free 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
f038b713-0721-2bb5-e053-2a95a90a7842Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-989-01Sugar Free Cough Drops140 in 1 BAGPASTILLE1403

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 174 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
application number: M012
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
application number: M012
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab860c10-b8cf-3f92-e053-2a95a90a73172023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
application number: M012
Universal Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUSUniversal Distribution Center LLCb1d25572-da21-408d-aab3-3a0741dfff122023-11-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION09286d15-b63f-a9de-e063-6294a90ab9482023-11-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6cece6c-23e4-7811-e053-6394a90a106a2023-11-02WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476973menthol 5.8 MG Oral LozengePSNf038b713-0721-2bb5-e053-2a95a90a78423
476973menthol 5.8 MG Oral LozengeSCDf038b713-0721-2bb5-e053-2a95a90a78423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-989-0151316098901140 PASTILLE in 1 BAG (51316-989-01) 140 pastille2025-06-26NoNoCurrent