Home NDC 0280-1012 Phillips Stool Softener
Product NDC 0280-1012
11-digit product format 002801012
Labeler code 0280
Product ID 0280-1012_4523911f-9d9b-4b0c-e063-6394a90ac76d
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bayer HealthCare LLC.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-09-02
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0280-1012-30 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0280-1012-30 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0280-1012-60 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 0280-1012-05 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 0280-1012-05 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
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 Phillips Stool Softener
Brand name suffix Bulk Docusate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115005 Internal RxNorm lookup 1248002 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-1012-30 Phillips Stool SoftenerBulk Docusate 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 14 0280-1012-30 Phillips Stool SoftenerBulk Docusate 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 14 0280-1012-60 Phillips Stool SoftenerBulk Docusate 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 14 0280-1012-60 Phillips Stool SoftenerBulk Docusate 60 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 60 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 DOCUSATE ACTIVE MOIETY M7P27195AG PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC, CONSUMER CARE] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-1012 PHILLIPS STOOL SOFTENER BULK DOCUSATE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.] 13 Current NDC, Legacy NDC, 4 package rows 20241027_b0462555-5554-4a17-a1fe-4206a4fd350d.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 43 · 858 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0280-1012-30 00280101230 1 BOTTLE, PLASTIC in 1 CARTON (0280-1012-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2015-05-19 0000-00-00 No No Current 0280-1012-60 00280101260 1 BOTTLE, PLASTIC in 1 CARTON (0280-1012-60) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2015-05-19 0000-00-00 No No Current