FDA.reportPublic FDA data

Herbal Throat Drops Lemon Mint Herb

Product NDC
76162-060
11-digit product format
761620060
Labeler code
76162
Product ID
76162-060_2fa086b4-3b0f-0df8-e063-6294a90a6769
Type
HUMAN OTC DRUG
Nonproprietary name
Throat Drops
Dosage form
PASTILLE
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-05
Substance
MENTHOL
Active strength
1.1 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
Herbal Throat Drops Lemon Mint Herb
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.1 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
701201Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fa086b4-3b0e-0df8-e063-6294a90a6769Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-060-01Herbal Throat Drops Lemon Mint Herb45 in 1 BAGPASTILLE451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-060HERBAL THROAT DROPS LEMON MINT HERB (THROAT DROPS) PASTILLE [TOPCO ASSOCIATES LLC]1Current NDC, 1 package rows20250309_2fa086b4-3b0e-0df8-e063-6294a90a6769.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 138 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact identifier
application number: M012
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
701201menthol 1.1 MG Oral LozengePSN2fa086b4-3b0e-0df8-e063-6294a90a67691
701201menthol 1.1 MG Oral LozengeSCD2fa086b4-3b0e-0df8-e063-6294a90a67691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-060-017616200600145 PASTILLE in 1 BAG (76162-060-01) 45 pastille2025-03-05NoNoCurrent