FDA.reportPublic FDA data

CounterAct

Product NDC
54473-132
11-digit product format
544730132
Labeler code
54473
Product ID
54473-132_51dfa5f9-fd63-36b4-e063-6394a90a864f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Melaleuca, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-05-20
Substance
MENTHOL
Active strength
7 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
CounterAct
Brand name suffix
Cough Drops Honey Lemon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL7 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
253015Internal RxNorm lookup
1112209Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84ac3489-9d64-401f-ab78-715af4de5440Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-132-302020-03-19C16284748780-19d75b9d0-1177-f424-e053-dadaa90a57ceCounterAct Cough Drops Honey Lemon Content of Label
54473-132-302020-01-31C16284748780-19d75b9d0-1177-f424-e053-dadaa90a57ceCounterAct Cough Drops Honey Lemon Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-132-07CounterActCough Drops Honey Lemon30 in 1 BAGLOZENGE308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ACOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
BETA CAROTENEINACTIVE INGREDIENT01YAE03M7JCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
HONEYINACTIVE INGREDIENTY9H1V576FHCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
LEMON OILINACTIVE INGREDIENTI9GRO824LLCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH8359COUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554COUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GCOUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-132COUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]7Current NDC, Legacy NDC, 1 package rows20250303_84ac3489-9d64-401f-ab78-715af4de5440.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 1 of 191 · 3,814 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112209CounterAct Cough Drops 7 MG Oral LozengePSN84ac3489-9d64-401f-ab78-715af4de54408
253015menthol 7 MG Oral LozengePSN84ac3489-9d64-401f-ab78-715af4de54408
1112209menthol 7 MG Oral Lozenge [Counteract Cough Drops]SBD84ac3489-9d64-401f-ab78-715af4de54408
253015menthol 7 MG Oral LozengeSCD84ac3489-9d64-401f-ab78-715af4de54408
1112209Counteract Cough Drops 7 MG Oral LozengeSY84ac3489-9d64-401f-ab78-715af4de54408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-132-075447301320730 LOZENGE in 1 BAG (54473-132-07) 30 lozenge2018-01-01NoNoCurrent
54473-132-305447301323030 LOZENGE in 1 BAG (54473-132-30) 30 lozenge2018-01-010000-00-00NoNoCurrent