Antispetic

Product NDC
53942-664
11-digit product format
539420664
Labeler code
53942
Product ID
53942-664_49f102b7-c27f-c5b1-e063-6394a90af220
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
505G9a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050593-001ERYC SPRINKLESERYTHROMYCIN125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-223f01610625f2…
2019-09-15 20:21 UTC2019-09N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050593-001ERYC SPRINKLES125MGCAPSULE, DELAYED REL PELLETS / ORAL1985-07-22e64feba35796…

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 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
c346f4e8-3990-49f1-aa8c-410c2f6265a3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150016
53942-664-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50016
53942-664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
THYMOLACTIVE INGREDIENT3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
MENTHOLACTIVE MOIETYL7T10EIP3AANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
THYMOLACTIVE MOIETY3J50XA376EANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]15Current NDC, Legacy NDC, 3 package rows20250507_c346f4e8-3990-49f1-aa8c-410c2f6265a3.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
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDemoulas Super Markets, Incc346f4e8-3990-49f1-aa8c-410c2f6265a32026-02-03Warnings, Adverse reactionsExact identifier
ndc (product): 53942-664

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNc346f4e8-3990-49f1-aa8c-410c2f6265a316
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDc346f4e8-3990-49f1-aa8c-410c2f6265a316
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYc346f4e8-3990-49f1-aa8c-410c2f6265a316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-664-12539420664121500 mL in 1 BOTTLE, PLASTIC (53942-664-12) 1500 ml2022-03-310000-00-00NoNoCurrent
53942-664-7753942066477500 mL in 1 BOTTLE, PLASTIC (53942-664-77) 500 ml1998-03-150000-00-00NoNoCurrent
53942-664-86539420664861000 mL in 1 BOTTLE, PLASTIC (53942-664-86) 1000 ml1998-03-150000-00-00NoNoCurrent