FDA.reportPublic FDA data

NDC 49580-0334-06 - Mineral oil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49580-0334
Requested NDC
49580-0334-06
Package NDCs from labels
49580-0334-6, 49580-0334-06
Manufacturer
P & L Development, LLC
Effective date
2025-02-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mineral oil - P & L Development, LLCP & L Development, LLC2025-02-21HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0334-6Mineral oil473 mL in 1 BOTTLEOIL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0334MINERAL OIL OIL [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 1 package rows20250224_68e88119-1468-4ab7-a5fa-242d960d25df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49580-0334-6ML - Milliliter49580-0334ee164ae0-79e5-4245-8f4f-360fe24652f212024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPMINERAL OIL OIL [AARON INDUSTRIES INC.]1
MINERAL OILACTIVE MOIETYT5L8T28FGPMINERAL OIL OIL [AARON INDUSTRIES INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MINERAL OIL OIL [AARON INDUSTRIES INC.]1

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 5 of 48 · 942 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
application number: M007
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
application number: M007
LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6103fded-622c-4551-9f32-ca1da44683ac2026-07-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.800fa966-077d-4624-9e36-75fe8863dad02026-07-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESBryant Ranch Prepackbdcf37fc-3938-4d3f-b669-35c6939eac4f2026-07-10WarningsExact identifier
application number: M007
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
unii: T5L8T28FGP
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEPreferred Pharmaceuticals Inc.f8bba8cb-a111-4285-8bdb-2273a049c3bb2026-07-08WarningsExact identifier
application number: M007
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
unii: T5L8T28FGP
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
application number: M007
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
application number: M007
SennaSENNOSIDES 8.6 MG TABLETSAarkish Pharmaceuticals NJ Inc.564bc9a5-13b5-4cce-a349-6b2e122683ed2026-07-01WarningsExact identifier
application number: M007
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
application number: M007
ENEMEEZDOCUSATE SODIUMQuest Products, LLC0b06445d-0839-497e-bdff-e0fe224a77382026-06-30WarningsExact identifier
application number: M007
ENEMEEZ PlusDOCUSATE SODIUM AND BENZOCAINEQuest Products, LLC1670ca59-7275-4ac6-bef4-674a7b24c7b32026-06-30WarningsExact identifier
application number: M007
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsExact identifier
application number: M007
unii: T5L8T28FGP
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application number: M007
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens20c43036-830b-0e1d-e063-6394a90adf5f2026-06-25WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAmerican Health Packagingbe7cab51-ce7e-465d-95db-083e69288cfd2026-06-25WarningsExact identifier
application number: M007

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.