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 6 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012
CVS Adult Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY822d5bf6-8841-4b7f-bbf7-90c3d50b80242026-08-19WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
application number: M012
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
application number: M012
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
application number: M012
rugby cough syrupDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories89752c69-25c8-45e3-9021-f81b35b52d362026-08-19WarningsExact identifier
application number: M012
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact 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