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 10 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Winco Original Formula Eye DropsTETRAHYDROZOLINE HCLWinCo Foods, LLC44266952-4054-4c12-b3fc-d0543fe54fe22025-12-30WarningsExact identifier
application number: M018
Winco Irritation Relief EyeTETRAHYDROZOLINE HCL, ZINC SULFATEWinCo Foods, LLC60565184-5745-43a5-92b2-ab45b27e8bc62025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
application number: M018
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBest Choice (Valu Merchandisers Company)f5e665e4-ebd7-8c35-e053-2995a90a88112025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
application number: M018
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
application number: M018
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLCf710d107-0403-21c5-e053-6394a90a03722025-12-30WarningsExact identifier
application number: M018
CVS Astringent EyeTETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.07e1a56b-fdad-408d-bf5a-7a0144ece1312025-12-30WarningsExact identifier
application number: M018
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
application number: M018
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCVS Pharmacy, Inc.8eef499d-c60e-9468-e053-2995a90a87142025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
application number: M018
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
application number: M018
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
application number: M018
CareOne Itchy Relief Eye Drops 15mLTETRAHYDROZOLINE HCI, ZINC SULFATERetail Business Services, LLC.997f16ff-2632-2e9d-e053-2995a90a6f512025-12-30WarningsExact identifier
application number: M018
Foster and Thrive Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLStrategic Sourcing Services LLC0042e9a0-9693-d7e0-e063-6294a90ae6c62025-12-30WarningsExact 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