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 145 of 177 · 3,525 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
DizzyCEREBELLUM (SUIS), BRYONIA (ALBA), PETROLEUM, TABACUM, AMBRA GRISEA, CYCLAMEN EUROPAEUM, NATRUM SALICYLICUM, ARGENTUM NITRICUM, ASARUM CANADENSE, CALCAREA SULPHURICA, CARBONEUM SULPHURATUM, CHININUM SULPHURICUM, COCCULUS INDICUS, CONIUM MACULATUM, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, PIPER METHYSTICUM, SILICEA, THERIDIONDeseret Biologicals, Inc.fdf934f8-7b12-4076-b8fb-00c0959406972024-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
unii: 15FIX9V2JP
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
rxcui: 998740
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
rxcui: 998740
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
unii: 15FIX9V2JP
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
unii: 15FIX9V2JP
DEXTROSEDEXTROSEB. Braun Medical Inc.085614c7-ada4-4e2c-87c0-c9bc2f18365a2024-03-12Warnings, Adverse reactionsExact identifier
unii: IY9XDZ35W2
VerARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALISDeseret Biologicals, Inc.b47bdd57-14cd-46e9-a34e-0d8a7c21bda22024-03-12WarningsExact identifier
unii: ETJ7Z6XBU4
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
unii: 15FIX9V2JP
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
SpinalmaxBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUMDeseret Biologicals, Inc.6c569331-2167-44bb-ace6-13340e7d8d6a2024-03-11WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUMDeseret Biologicals, Inc.81f29472-a2e6-486d-aefd-17135ad410ef2024-03-08WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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