FDA.reportPublic FDA data

Soothe

Product NDC
24208-495
11-digit product format
242080495
Labeler code
24208
Product ID
24208-495_22996336-b8b3-8ee6-e063-6394a90a8537
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin and propylene glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-08-26
Substance
GLYCERIN; PROPYLENE GLYCOL
Active strength
6; 6 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24208-49524208-495-28DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN6 mg/mL
PROPYLENE GLYCOL6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
832115Internal RxNorm lookup
1098601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fef002ea-c4bd-4486-a42e-1bbd9d73d28dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-495-28Soothe28 in 1 CARTONSOLUTION/ DROPS2810
24208-495-28Soothe0.6 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.610
24208-495-30Soothe0.6 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.610
24208-495-30Soothe30 in 1 CARTONSOLUTION/ DROPS3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXSOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3SOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
GLYCERINACTIVE MOIETYPDC6A3C0OXSOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3SOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQSOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOSOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-495SOOTHE (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]10Current NDC, Legacy NDC, 4 package rows20240922_fef002ea-c4bd-4486-a42e-1bbd9d73d28d.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
832115glycerin 0.6 % / propylene glycol 0.6 % Ophthalmic SolutionPSNfef002ea-c4bd-4486-a42e-1bbd9d73d28d10
1098601Soothe Lubricant 0.6 % / 0.6 % Ophthalmic SolutionPSNfef002ea-c4bd-4486-a42e-1bbd9d73d28d10
1098601glycerin 6 MG/ML / propylene glycol 6 MG/ML Ophthalmic Solution [Soothe Lubricant Eye Drops]SBDfef002ea-c4bd-4486-a42e-1bbd9d73d28d10
832115glycerin 6 MG/ML / propylene glycol 6 MG/ML Ophthalmic SolutionSCDfef002ea-c4bd-4486-a42e-1bbd9d73d28d10
832115glycerin 0.6 % / propylene glycol 0.6 % Ophthalmic SolutionSYfef002ea-c4bd-4486-a42e-1bbd9d73d28d10
1098601Soothe Lubricant Eye Drops (glycerin 0.6 % / propylene glycol 0.6 % ) Ophthalmic SolutionSYfef002ea-c4bd-4486-a42e-1bbd9d73d28d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-495-282420804952828 VIAL, SINGLE-USE in 1 CARTON (24208-495-28) > .6 mL in 1 VIAL, SINGLE-USE2010-08-260000-00-00NoNoCurrent
24208-495-302420804953030 VIAL, SINGLE-USE in 1 CARTON (24208-495-30) / .6 mL in 1 VIAL, SINGLE-USE2020-05-010000-00-00NoNoCurrent