FDA.reportPublic FDA data

Menthol cough drops

Product NDC
55319-006
11-digit product format
553190006
Labeler code
55319
Product ID
55319-006_45c717b7-bc54-ef17-e063-6394a90a72ba
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Family Dollar
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-24
Substance
MENTHOL
Active strength
5.4 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
Menthol cough drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.4 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
485287Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44bb3b95-b2ba-470e-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-006-30Menthol cough drops30 in 1 BAGLOZENGE309
55319-006-80menthol cough drops80 in 1 BAGLOZENGE809

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-006MENTHOL COUGH DROPS (MENTHOL) LOZENGE [FAMILY DOLLAR]8Current NDC, Legacy NDC, 1 package rows20241203_44bb3b95-b2ba-470e-e054-00144ff88e88.zip
55319-006MENTHOL COUGH DROPS (MENTHOL) LOZENGE [FAMILY DOLLAR]8Current NDC, Legacy NDC, 1 package rows20241203_44bb9c7b-994b-4ab8-e054-00144ff8d46c.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 136 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012
Equate Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalmart6271bb48-74b2-eb57-e053-2991aa0afd1b2024-11-13WarningsExact identifier
application number: M012
Equaline Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEUnited Natural Foods, Inc. dba UNFI6bf341e0-94b1-08ff-e053-2991aa0af6342024-11-13WarningsExact identifier
application number: M012
Good Sense Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEGood Sensecd25e250-bb8b-7e83-e053-2a95a90a26392024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd440a00b1-7960-0cc4-e054-00144ff8d46c2024-11-13WarningsExact identifier
application number: M012
Top Value Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATETower Laboratories Ltd.c6f207e8-bc0d-853a-e053-2a95a90ac6232024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEDOLGENCORP, LLC7fad8e65-34fe-5313-e053-2a91aa0a56f42024-11-13WarningsExact identifier
application number: M012
Dollar General Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATEDOLGENCORP, LLC7face5c7-f5c7-7eee-e053-2991aa0ab0642024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEChain Drug Marketing Association90622927-9682-4eb0-8c7f-894230b3dda42024-11-13WarningsExact identifier
application number: M012
Quality Choice Effervescent Cold Relief - OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEChain Drug Marketing Association9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca2024-11-13WarningsExact identifier
application number: M012
WinCo Foods Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEWinCo Foods, LLCd443a030-d3d6-40e0-8fe0-329de6bc494f2024-11-13WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Company954fe703-9a10-4354-8b71-4d98a22a0b9f2024-11-13WarningsExact identifier
application number: M012
NASAL DECONGESTANT PEPHENYLEPHRINE HCLA-S Medication Solutions9d030767-dfd6-48b4-9b17-4e20c23915f32024-11-13WarningsExact identifier
application number: M012
Childrens SUDAFED PE Cold plus CoughDEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC20e45243-3989-413a-bcf1-49d754ff2e442024-11-12WarningsExact identifier
application number: M012
Tukol Cough And Cold Honey FlavorDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAa4b333dc-58da-45db-87b6-6fcb8fb542b82024-11-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485287menthol 5.4 MG Oral LozengePSN44bb3b95-b2ba-470e-e054-00144ff88e889
485287menthol 5.4 MG Oral LozengePSN44bb9c7b-994b-4ab8-e054-00144ff8d46c9
485287menthol 5.4 MG Oral LozengeSCD44bb3b95-b2ba-470e-e054-00144ff88e889
485287menthol 5.4 MG Oral LozengeSCD44bb9c7b-994b-4ab8-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-006-305531900063030 LOZENGE in 1 BAG (55319-006-30) 30 lozenge2013-05-240000-00-00NoNoCurrent
55319-006-805531900068080 LOZENGE in 1 BAG (55319-006-80) 80 lozenge2013-05-240000-00-00NoNoCurrent