Antiseptic

Product NDC
59779-072
Requested package NDC
59779-072-77
11-digit product format
597790072
Labeler code
59779
Product ID
59779-072_49dbf3b4-500d-86ae-e063-6294a90a09c1
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-08-09
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-07259779-072-77DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
Antiseptic
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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06755465-7a74-40f8-9dd4-dbe24b8fec2aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
59779-072-12Antiseptic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150018
59779-072-69Antiseptic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25018
59779-072-77Antiseptic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50018
59779-072-86Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
THYMOLACTIVE MOIETY3J50XA376EANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [CVS PHARMACY, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-072ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CVS PHARMACY, INC]15Current NDC, Legacy NDC, 4 package rows20250228_06755465-7a74-40f8-9dd4-dbe24b8fec2a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCVS Pharmacy, Inc.06755465-7a74-40f8-9dd4-dbe24b8fec2a2026-02-02Warnings, Adverse reactionsExact identifier
ndc (package): 59779-072-77
ndc (product): 59779-072
ndc11 (package): 59779007277

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN06755465-7a74-40f8-9dd4-dbe24b8fec2a18
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD06755465-7a74-40f8-9dd4-dbe24b8fec2a18
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY06755465-7a74-40f8-9dd4-dbe24b8fec2a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-072-7759779007277500 mL in 1 BOTTLE, PLASTIC (59779-072-77) 500 ml1995-08-090000-00-00NoNoCurrent