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
2026-12-31
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
2026-12-31

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 1 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
application number: M018
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
application number: M018
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
application number: M018
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
application number: M018
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
application number: M018
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
application number: M018
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
application number: M018
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
application number: M018
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
application number: M018
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
application number: M018
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
application number: M018
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
application number: M018
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact 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