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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact 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