FDA.reportPublic FDA data

Promolaxin

Product NDC
27495-012
11-digit product format
274950012
Labeler code
27495
Product ID
27495-012_b3db505a-9663-6f5a-e053-2a95a90a13d4
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Physicians Science & Nature Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-15
Marketing end
2020-12-31
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct27495-012DDiscontinued by firm2026-10-12
excluded packagepackage27495-01227495-012-01DDiscontinued by firm2026-10-12

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage27495-012-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage27495-012-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage27495-012-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27495-012-01EA - Each27495-0125f0510fa-a0b3-4e9b-a9e1-ce7be23ce5f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0PROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27495-012PROMOLAXIN (DOCUSATE SODIUM) TABLET [PHYSICIANS SCIENCE & NATURE INC.]4Legacy NDC20241216_72d8e93e-d6a7-47f3-8e10-4bab34eb699a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099279docusate sodium 100 MG Oral TabletPSN80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099279docusate sodium 100 MG Oral TabletPSNf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099279docusate sodium 100 MG Oral TabletPSN9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099281Promolaxin 100 MG Oral TabletPSNf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099281Promolaxin 100 MG Oral TabletPSN80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099281Promolaxin 100 MG Oral TabletPSN9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099281docusate sodium 100 MG Oral Tablet [Promolaxin]SBDf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099281docusate sodium 100 MG Oral Tablet [Promolaxin]SBD80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099281docusate sodium 100 MG Oral Tablet [Promolaxin]SBD9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099279docusate sodium 100 MG Oral TabletSCDf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099279docusate sodium 100 MG Oral TabletSCD9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099279docusate sodium 100 MG Oral TabletSCD80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099279DOSS Sodium 100 MG Oral TabletSY9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099279DOSS Sodium 100 MG Oral TabletSY80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099279DOSS Sodium 100 MG Oral TabletSYf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099281DOSS Sodium 100 MG Oral Tablet [Promolaxin]SY9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099281DOSS Sodium 100 MG Oral Tablet [Promolaxin]SYf32e1b05-8623-4410-b76a-bd0ca6b928d01
1099281DOSS Sodium 100 MG Oral Tablet [Promolaxin]SY80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099281Promolaxin 100 MG Oral TabletSY9d94a91b-638b-41e5-81e0-cd8c13bdfdb81
1099281Promolaxin 100 MG Oral TabletSY80a2306a-d5a2-4c10-9b3c-d21f9915f9e51
1099281Promolaxin 100 MG Oral TabletSYf32e1b05-8623-4410-b76a-bd0ca6b928d01