FDA.reportPublic FDA data

Soothe XP Preservative Free

Product NDC
24208-742
11-digit product format
242080742
Labeler code
24208
Product ID
24208-742_2298b766-e9e4-0319-e063-6394a90a50dc
Type
HUMAN OTC DRUG
Nonproprietary name
light mineral oil and mineral oil
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-18
Substance
LIGHT MINERAL OIL; MINERAL OIL
Active strength
10; 45 mg/mL; 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
Soothe XP Preservative Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIGHT MINERAL OIL10 mg/mL
MINERAL OIL45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6K5787QVPInternal UNII lookup
T5L8T28FGPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577927Internal RxNorm lookup
1594962Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b254d885-6d49-4c95-b6be-cfdad49c85e6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-742-01Soothe XP Preservative Free0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.36
24208-742-01Soothe XP Preservative Free30 in 1 CARTONSOLUTION/ DROPS306
24208-742-99Soothe XP Preservative Free0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.36
24208-742-99Soothe XP Preservative Free5 in 1 POUCHSOLUTION/ DROPS56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-742SOOTHE XP PRESERVATIVE FREE (LIGHT MINERAL OIL AND MINERAL OIL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6Current NDC, Legacy NDC, 4 package rows20240922_b254d885-6d49-4c95-b6be-cfdad49c85e6.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 2 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
application number: M018
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
application number: M018
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
application number: M018
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577927light mineral oil 1 % / mineral oil 4.5 % Ophthalmic SolutionPSNb254d885-6d49-4c95-b6be-cfdad49c85e66
1594962Soothe XP Mineral Oil 1 % / 4.5 % Ophthalmic SolutionPSNb254d885-6d49-4c95-b6be-cfdad49c85e66
1594962mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic Solution [Soothe Mineral Oil]SBDb254d885-6d49-4c95-b6be-cfdad49c85e66
577927mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic SolutionSCDb254d885-6d49-4c95-b6be-cfdad49c85e66
577927mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic SolutionSYb254d885-6d49-4c95-b6be-cfdad49c85e66
1594962mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic Solution [Soothe Mineral Oil]SYb254d885-6d49-4c95-b6be-cfdad49c85e66
1594962Soothe Mineral Oil 4.5 % / 1 % Ophthalmic SolutionSYb254d885-6d49-4c95-b6be-cfdad49c85e66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-742-012420807420130 VIAL, SINGLE-USE in 1 CARTON (24208-742-01) / .3 mL in 1 VIAL, SINGLE-USE2018-04-180000-00-00NoNoCurrent
24208-742-99242080742995 VIAL, SINGLE-USE in 1 POUCH (24208-742-99) / .3 mL in 1 VIAL, SINGLE-USE2018-08-220000-00-00NoNoCurrent