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 46 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and NighttimeACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP43da4211-3bb3-0a8e-e063-6294a90a4fcd2026-03-16WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLKroger Companyab12c975-2085-4365-9c4b-0be573a260c42026-03-13WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC88e3e51a-c9a5-43f9-b9d7-97509c607df12026-03-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCLRB Health (US) LLC4cc490a6-a27a-a25b-e063-6294a90a3a952026-03-11WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCba6d69ff-b392-4f21-b3d7-00d8ec5dee322026-03-11WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEB40091b98-b4c7-4a3b-e063-6294a90abd5d2026-03-10WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEUnited Natural Foods, Inc. dba UNFI0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATETopco Associates, LLC35305aa9-4fc1-4cda-b6f0-89df64f9eeff2026-03-10WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway03332596-2c37-4771-b13b-ab766e6168662026-03-10WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief Maximum StrengthPSEUDOEPHEDRINE HCLRite Aid Corporationd86140ab-1117-4d14-a380-f5cc375775a12026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN4c9cca86-41bf-1635-e063-6294a90a17fb2026-03-09WarningsExact identifier
application number: M012
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.447a8753-96bd-676a-e063-6394a90a48f22026-03-06WarningsExact 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