FDA.reportPublic FDA data

Antiseptic

Product NDC
55301-210
11-digit product format
553010210
Labeler code
55301
Product ID
55301-210_c28e412b-16f0-456a-ad18-a57a256f40b6
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Exchange Select
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-10-18
Marketing end
0000-00-00
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
0 mL/100L; mL/100L; mL/100L; mL/100L
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55301-210-862025-11-05C16284748780-19d75b9d0-3f19-f424-e053-dadaa90a57ceDrug Facts
55301-210-862020-01-31C16284748780-19d75b9d0-3f19-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-210ANTISEPTIC (EUCALYPTOL) MOUTHWASH [EXCHANGE SELECT]1Legacy NDC20120402_e32aa65b-ad9c-4d22-9a6c-0c8aca983e2d.zip