Mineral oil

Product NDC
49035-035
11-digit product format
490350035
Labeler code
49035
Product ID
49035-035_abe12f54-7949-4ae8-90ba-0a5031c0fad3
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil
Dosage form
OIL
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-31
Marketing end
2027-08-28
Substance
MINERAL OIL
Active strength
100 mg/100mL
NDC exclude flag
No
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
Mineral oil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL100 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92f2147d-b52d-4282-b217-28f6095dca0eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-035-16Mineral oil473 mL in 1 BOTTLEOIL4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-035-16ML - Milliliter49035-0350ed63aee-ff71-4522-b2d8-6d26323cac6612017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPMINERAL OIL OIL [EQUATE (WALMART STORES, INC.)]1
MINERAL OILACTIVE MOIETYT5L8T28FGPMINERAL OIL OIL [EQUATE (WALMART STORES, INC.)]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MINERAL OIL OIL [EQUATE (WALMART STORES, INC.)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-035MINERAL OIL OIL [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]7Current NDC, Legacy NDC, 1 package rows20250209_92f2147d-b52d-4282-b217-28f6095dca0e.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 14 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENTLE LAXATIVEBISACODYLWal-Mart Stores Inc9b466e37-4c7d-4237-8a9d-2994113707f42026-01-26WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Laboratories Limited3cf42333-7479-940a-e063-6394a90aedee2026-01-23WarningsExact identifier
application number: M007
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2de868a0-c652-473c-8b61-636083b7f7572026-01-22WarningsExact identifier
application number: M007
Dr Simi Regular Strength Sennosides 8.6mgSENNOSIDES 8.6MGFarmacias De Similares TX LLC48ed4c5a-136a-90ba-e063-6294a90affed2026-01-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC1f6c3b64-0fcd-4cd3-9947-453d794682922026-01-19WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreensd094ba43-7404-43c4-b907-41ab6d02a3c32026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens015e41d2-7543-4210-8345-626f5ae5f81d2026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens2c30de62-b5d2-4905-90a1-a2f9a339fb272026-01-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)0ce164a5-6b2f-4a21-9dca-10301a1f812a2026-01-15WarningsExact identifier
application number: M007
Dulcolax Pink Stool SoftenerDOCUSATE SODIUMChattem, Inc.33fefcf1-9985-4797-9a38-8acaf3979fce2026-01-14WarningsExact identifier
application number: M007
SennaSENNOSIDESAmerican Health Packaginge3cbb71b-b45c-4ce1-820b-959dde04360d2026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy9c6a651a-f062-4784-9d82-156f9f7452232026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy10a9bd9a-181b-69ba-e063-6294a90ac4582026-01-14WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-035-1649035003516473 mL in 1 BOTTLE (49035-035-16) 473 ml2014-10-312027-08-28NoNoCurrent