FDA.reportPublic FDA data

Soothe Night Time

Product NDC
24208-313
11-digit product format
242080313
Labeler code
24208
Product ID
24208-313_22e15dc4-1977-7228-e063-6394a90a679a
Type
HUMAN OTC DRUG
Nonproprietary name
white petrolatum mineral oil
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-15
Substance
MINERAL OIL; PETROLATUM
Active strength
200; 800 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct24208-313EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage24208-31324208-313-34EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 Night Time
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL200 mg/g
PETROLATUM800 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259196Internal RxNorm lookup
1235262Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
638d3c3f-9960-43da-956e-0e28c77f533eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-313-34Soothe Night Time3.5 g in 1 TUBEOINTMENT3.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-313-34GM - Gram24208-3138ba2d21d-2b7d-4273-912c-20b17dfde80512025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPSOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9USOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]1
MINERAL OILACTIVE MOIETYT5L8T28FGPSOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]1
PETROLATUMACTIVE MOIETY4T6H12BN9USOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-313SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 1 package rows20240927_638d3c3f-9960-43da-956e-0e28c77f533e.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 · 499 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
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentPSN638d3c3f-9960-43da-956e-0e28c77f533e8
1235262Soothe Night Time 20 % / 80 % Ophthalmic OintmentPSN638d3c3f-9960-43da-956e-0e28c77f533e8
1235262mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic Ointment [Soothe Night Time]SBD638d3c3f-9960-43da-956e-0e28c77f533e8
259196mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic OintmentSCD638d3c3f-9960-43da-956e-0e28c77f533e8
1235262Bausch & Lomb Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic OintmentSY638d3c3f-9960-43da-956e-0e28c77f533e8
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentSY638d3c3f-9960-43da-956e-0e28c77f533e8
1235262Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic OintmentSY638d3c3f-9960-43da-956e-0e28c77f533e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-313-34242080313343.5 g in 1 TUBE (24208-313-34) 3.5 g2011-11-150000-00-00NoNoCurrent