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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
application number: M018
blink boostGLYCERINBausch & Lomb Incorporatede765c224-1718-488f-99b2-976eb60c1d632026-04-13WarningsExact identifier
application number: M018
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
application number: M018
WE FRESH Lubricating Eye DropsGLYCERINOculus Surgical, Inc.4f253b5d-001b-091e-e063-6394a90a9d392026-04-09WarningsExact identifier
application number: M018
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
application number: M018
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
application number: M018
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
application number: M018
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
application number: M018
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
application number: M018
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
application number: M018
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
application number: M018
NOVEHA NIGHTTIMEWHITE PETROLATUMBullet Point LLC4da24578-e98b-8ce1-e063-6294a90a8bf62026-03-24WarningsExact identifier
application number: M018
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
application number: M018
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact 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