FDA.reportPublic FDA data

Cough Drops Menthol Honey Lemon

Product NDC
70000-0639
11-digit product format
700000639
Labeler code
70000
Product ID
70000-0639_0f47e3cf-a2cc-dc95-e063-6294a90aed99
Type
HUMAN OTC DRUG
Nonproprietary name
Cough Drops Menthol
Dosage form
PASTILLE
Route
ORAL
Labeler
Cardinal Health 110, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-17
Substance
MENTHOL
Active strength
7.5 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
Cough Drops Menthol Honey Lemon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7.5 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
1250189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe5b3f6d-2a2d-f322-e053-6394a90aba04Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0639-1Cough Drops Menthol Honey Lemon30 in 1 BAGPASTILLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0639COUGH DROPS MENTHOL HONEY LEMON (COUGH DROPS MENTHOL) PASTILLE [CARDINAL HEALTH 110, INC.]2Current NDC, 1 package rows20240120_fe5b3f6d-2a2d-f322-e053-6394a90aba04.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 90 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e2025-11-07WarningsExact identifier
application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Companyff0bffee-9a36-8246-e053-6294a90a86c72025-11-06WarningsExact identifier
application number: M012
Xlear Nasal DecongestantNASAL SPRAYXlear Inc.1c1db71a-47d0-42ac-8cbe-95e76dca185f2025-11-06WarningsExact identifier
application number: M012
Robitussin Honey Cough DM Day Night Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLC1bbd0157-06e6-4a3b-bac9-91ac879ba0892025-11-06WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant Phenylephrine HClPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.21676b0c-6be2-464c-ae91-92e5f0d0087d2025-11-06WarningsExact identifier
application number: M012
COLD AND FLU SEVERE Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.04715af5-e861-496c-834a-233eb73125562025-11-06WarningsExact identifier
application number: M012
Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores Inc1a1f41c4-5430-4cff-873e-6547dadc87792025-11-06WarningsExact identifier
application number: M012
Target Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION05e944d5-3473-4d8c-8df4-2ffc7474e9fa2025-11-05WarningsExact identifier
application number: M012
Target Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINTARGET CORPORATIONe36f179e-5aed-4fee-8b0a-767bf35907522025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d22025-11-05WarningsExact identifier
application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationf007beaa-b108-46d5-8a98-853f011a8e2e2025-11-05WarningsExact identifier
application number: M012
Target Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINTARGET CORPORATION975e157a-8f8d-41ad-b55b-9f9100188ccd2025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCLTARGET CORPORATION6e94fdab-27ea-4c0f-a91c-735ce697304b2025-11-05WarningsExact identifier
application number: M012
Target Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation76299495-7259-4bbe-8393-7eabfe22715a2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGHBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLTARGET CORPORATION05ac2a40-5eee-4013-b55b-6e370a28b21c2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENs COLD and COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATIONeb912834-1b14-484d-90f7-a8deb52c0d4e2025-11-05WarningsExact identifier
application number: M012
UP and UP Daytime Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationa2d99bc8-7295-4922-acff-0cb02c91273c2025-11-05WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILAMERISOURCE BERGENc1843f1a-ae5b-0fdf-e053-2995a90aae382025-11-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4754363d-e163-42e0-a65d-1c4bac24f6c92025-11-05WarningsExact identifier
application number: M012
Day Time Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLSafeway, Inc.76d62892-615d-4744-95aa-3be1207a0e572025-11-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250189menthol 7.5 MG Oral LozengePSNfe5b3f6d-2a2d-f322-e053-6394a90aba042
1250189menthol 7.5 MG Oral LozengeSCDfe5b3f6d-2a2d-f322-e053-6394a90aba042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0639-17000006390130 PASTILLE in 1 BAG (70000-0639-1) 30 pastille2023-06-17NoNoCurrent