FDA.reportPublic FDA data

Cough and Cold Therapy For Kids

Product NDC
83670-201
11-digit product format
836700201
Labeler code
83670
Product ID
83670-201_2cb2d3da-78ac-4420-e063-6394a90a771a
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Eucalyptus Oil
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Everlaan Organics Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-14
Substance
CAMPHOR (NATURAL); MENTHOL; EUCALYPTUS OIL
Active strength
4.7; 2.6; 1.2 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83670-201-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83670-201-020efc9e666f02…f202fb6c5f17…

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
Cough and Cold Therapy For Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)4.7 g/100g
MENTHOL2.6 g/100g
EUCALYPTUS OIL1.2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup
2R04ONI662Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200293Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
088df369-114c-db4f-e063-6394a90acfacAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83670-201-02Cough and Cold Therapy For Kids1 in 1 CARTONOINTMENT13
83670-201-02Cough and Cold Therapy For Kids56 g in 1 JAROINTMENT563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83670-201COUGH AND COLD THERAPY FOR KIDS (CAMPHOR, MENTHOL, EUCALYPTUS OIL) OINTMENT [EVERLAAN ORGANICS INC]3Current NDC, 2 package rows20250129_088df369-114c-db4f-e063-6394a90acfac.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 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLArmy & Air Force Exchange Service3d7109a5-4fe1-039b-e063-6394a90a13922025-08-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3d710deb-e42d-13eb-e063-6394a90a56e12025-08-28WarningsExact identifier
application number: M012
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
application number: M012
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
application number: M012
Adult Bisolvine AdultGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.8cde5e39-a338-45af-b847-3823627f29c52025-08-25WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
application number: M012
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLVerityRx9ca6c0f8-71d1-4953-8e98-3311c46640112025-08-22WarningsExact identifier
application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum StrengthPHENYLEPHRINE HCLSalado Sales, Inc.9056fa58-d6aa-4df5-97e0-9be3f2332f862025-08-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
application number: M012
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200293camphor 4.7 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentPSN088df369-114c-db4f-e063-6394a90acfac3
200293camphor 0.047 MG/MG / Eucalyptus oil 0.012 MG/MG / menthol 0.026 MG/MG Topical OintmentSCD088df369-114c-db4f-e063-6394a90acfac3
200293camphor 4.7 % / eucalyptus oil 1.2 % / menthol 2.6 % Topical OintmentSY088df369-114c-db4f-e063-6394a90acfac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83670-201-02836700201021 JAR in 1 CARTON (83670-201-02) / 56 g in 1 JAR1 jar2023-09-14NoNoCurrent