FDA.reportPublic FDA data

Antispetic

Product NDC
63941-001
11-digit product format
639410001
Labeler code
63941
Product ID
63941-001_4af5870c-cca8-68e6-e063-6394a90a37b4
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Valu Merchandisers Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-06-09
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antispetic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui1043619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-001-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150016
63941-001-69Antispetic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25016
63941-001-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50016
63941-001-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
THYMOLACTIVE MOIETY3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-001ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VALU MERCHANDISERS CO.]15Current NDC, Legacy NDC, 4 package rows20250112_117b44ba-5313-40f6-97c4-035a7f039fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN117b44ba-5313-40f6-97c4-035a7f039fae16
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD117b44ba-5313-40f6-97c4-035a7f039fae16
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY117b44ba-5313-40f6-97c4-035a7f039fae16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-001-12639410001121500 mL in 1 BOTTLE, PLASTIC (63941-001-12) 1500 ml1995-06-090000-00-00NoNoCurrent
63941-001-6963941000169250 mL in 1 BOTTLE, PLASTIC (63941-001-69) 250 ml1995-06-090000-00-00NoNoCurrent
63941-001-7763941000177500 mL in 1 BOTTLE, PLASTIC (63941-001-77) 500 ml1995-06-090000-00-00NoNoCurrent
63941-001-86639410001861000 mL in 1 BOTTLE, PLASTIC (63941-001-86) 1000 ml1995-06-090000-00-00NoNoCurrent