Sweet Comfort

Product NDC
70983-003
11-digit product format
709830003
Labeler code
70983
Product ID
70983-003_48503e7b-ae58-b667-e063-6294a90a4561
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OIL
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
24.56 mg/mL
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
Sweet Comfort
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL24.56 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf13cccd-723d-4d61-8a5e-b36281605cc7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-003-04Sweet Comfort10 mL in 1 BOTTLE, DROPPEROIL105
70983-003-04Sweet Comfort1 in 1 BOXOIL15
70983-003-05Sweet Comfort6 mL in 1 BOTTLE, DROPPEROIL65
70983-003-05Sweet Comfort1 in 1 BOXOIL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-003SWEET COMFORT (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]4Current NDC, Legacy NDC, 4 package rows20231006_cf13cccd-723d-4d61-8a5e-b36281605cc7.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 129 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum No Mess Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyf4675bc1-01cc-4a33-a3bf-bfc99230fe322024-12-17WarningsExact identifier
application number: M012
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70983-003-04709830003041 BOTTLE, DROPPER in 1 BOX (70983-003-04) / 10 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
70983-003-05709830003051 BOTTLE, DROPPER in 1 BOX (70983-003-05) / 6 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent