Home NDC 0121-0544-16 Docusate Sodium
Product NDC 0121-0544
Requested package NDC 0121-0544-16
11-digit product format 001210544
Labeler code 0121
Product ID 0121-0544_b943532e-9ad6-9470-e053-2995a90af9f1
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form LIQUID
Route ORAL
Labeler Pharmaceutical Associates, Inc.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 1983-02-16
Marketing end 0000-00-00
Substance DOCUSATE SODIUM
Active strength 50 mg/5mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM LIQUID [CARDINAL HEALTH] 3 Docusate Sodium ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Docusate ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM LIQUID [PHARMACEUTICAL ASSOCIATES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-0544-16 00121054416 12 BOTTLE in 1 CASE (0121-0544-16) > 473 mL in 1 BOTTLE 12 bottle 1983-02-16 0000-00-00 No No Current