FDA.reportPublic FDA data

NDC 50488-0901-01 - Laxacin

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
50488-0901
Requested NDC
50488-0901-01
Package NDCs from labels
50488-0901-1, 50488-0901-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Laxacin - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN OTC DRUG LABEL
Laxacin - Alexso, IncAlexso, Inc2024-12-04HUMAN OTC DRUG LABEL
Laxacin - Quality Care Products, LLCQuality Care Products, LLC2023-12-21HUMAN OTC DRUG LABEL
LAXACIN - Direct_RxDirect_Rx2023-10-06HUMAN OTC DRUG LABEL
Laxacin Laxative Plus Stool SoftenerNuCare Pharmaceuticals,Inc.2021-02-11HUMAN OTC DRUG LABEL
Laxacin - medsource pharmaceuticalsmedsource pharmaceuticals2018-12-20HUMAN OTC DRUG LABEL
LAXACIN - DIRECT RXDIRECT RX2018-03-26HUMAN OTC DRUG LABEL
Laxacin Laxative Plus Stool SoftenerDispensing Solutions, Inc. | PSS World Medical, Inc.2013-07-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-0901-1Laxacin100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-0901LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO, INC]8Current NDC, Legacy NDC, 1 package rows20241208_0df9abaf-3997-4dde-8003-ae3d8d07cf39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-0901-1EA - Each50488-0901933d71c3-b01d-44ff-b256-0bee20827ae812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DOCUSATEACTIVE MOIETYM7P27195AGLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [DISPENSING SOLUTIONS, INC.]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42ENLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
DOCUSATEACTIVE MOIETYM7P27195AGLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SENNOSIDESACTIVE MOIETY3FYP5M0IJXLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ALEXSO 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 44 of 180 · 3,596 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
unii: 15FIX9V2JP
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F05Q2T2JA0
HM-B (EDIBLE VINEGAR)TITANIUM OXIDEDEMAND SERVICE, CO., LTD.9a7b1e74-b8af-449c-e053-2995a90a349e2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Calcarea Phosphorica 8002CALCAREA PHOSPHORICAProfessional Complementary Health Formulas555dd940-ed07-4160-bae3-1b4d320dec662026-01-08WarningsExact identifier
unii: L11K75P92J
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Calcarea Combination 9214CALCAREA COMBINATIONProfessional Complementary Health Formulas54b605d6-1e58-41b1-865b-1280ed75d4942026-01-08WarningsExact identifier
unii: L11K75P92J
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: L11K75P92J
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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