Original Herb Cough Drops

Product NDC
63667-933
11-digit product format
636670933
Labeler code
63667
Product ID
63667-933_5c2f5689-28bf-4599-bff0-5c945b490f43
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LOZENGE
Route
ORAL
Labeler
Ricola USA Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
MENTHOL
Active strength
5.5 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
Original Herb Cough Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.5 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
749548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ac9d95b-f6b9-4515-b126-697f8f839612Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63667-933-09Original Herb Cough Drops9 in 1 PACKAGELOZENGE93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63667-933ORIGINAL HERB COUGH DROPS (MENTHOL) LOZENGE [RICOLA USA INC.]3Current NDC, Legacy NDC, 1 package rows20241211_6ac9d95b-f6b9-4515-b126-697f8f839612.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 142 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Drops Honey Lemon with SugarMENTHOLLidl US LLC4ad9398f-7488-6eaf-e054-00144ff8d46c2024-11-05WarningsExact identifier
application number: M012
rexall dm cough and congestion reliefDEXTROMETHORPHAN HBR, GUAIFENESINDolgencorp, LLC906838b1-a742-4728-944d-42b687b8cd592024-11-05WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HBR, GUAIFENESINH E B7c24c59c-7549-4c64-95f8-4bf755cd6f612024-11-05WarningsExact identifier
application number: M012
equate adult tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inc3592e000-a6c6-47fe-8bb0-9341c65c29592024-11-05WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company756794b0-8d3b-4732-947c-a407caf400e22024-11-05WarningsExact identifier
application number: M012
basic care tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINAmazon.com Services LLCc6863e31-e1b9-40ff-ae2e-4aec86b4acc02024-11-05WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates LLC94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a2024-11-05WarningsExact identifier
application number: M012
Childrens Sudafed PE NASAL DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d2024-11-04WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.164b2559-2d3f-431e-a03c-07e86731af5c2024-11-04WarningsExact identifier
application number: M012
tussin severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E B7cc2c136-d1b7-4658-99bb-73bb1d1402612024-11-04WarningsExact identifier
application number: M012
dg health tussinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inca5d0ee70-d528-4a53-bf01-7bb13b364ed02024-11-04WarningsExact identifier
application number: M012
basic care tussin cf severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLCbba9a17d-eb87-46f3-acee-c9dd34e5bfd42024-11-04WarningsExact identifier
application number: M012
topcare tussin cf maxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCb553b7e6-933b-49e3-97d3-22a4643a04b92024-11-04WarningsExact identifier
application number: M012
dg health nasal originalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLCfb209752-705a-4bb0-9298-8b70357f39112024-11-02WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B3c301993-642a-487c-96a2-ebc4ef90dc882024-11-02WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1341744c-43c3-462b-b93c-1e46476fd9352024-11-01WarningsExact identifier
application number: M012
Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy43784616-1afd-4ff7-8fee-6ac389f616a22024-11-01WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLC28ef87e8-29e5-444d-b1f7-5c38a7f758d32024-11-01WarningsExact identifier
application number: M012
Good Sense Severe NightTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Company0e3c36c9-d45b-41b9-891d-a42d854295f92024-11-01WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company7dc3941a-e5f8-4caa-bae5-6a0d075295cb2024-11-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749548menthol 5.5 MG Oral LozengePSN6ac9d95b-f6b9-4515-b126-697f8f8396123
749548menthol 5.5 MG Oral LozengeSCD6ac9d95b-f6b9-4515-b126-697f8f8396123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63667-933-09636670933099 LOZENGE in 1 PACKAGE (63667-933-09) 9 lozenge2022-01-010000-00-00NoNoCurrent