FDA.reportPublic FDA data

ACETYLCYSTEINE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2016-03-03
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:16:26

Label at a glance#

ProductACETYLCYSTEINE
Active ingredientACETYLCYSTEINE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYLCYSTEINEWYQ7N0BPYCACTIB
ACETYLCYSTEINEWYQ7N0BPYCACTIB

Source Document#

Source XML

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 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetylcysteineACETYLCYSTEINEHospira, Inc.5558a5f5-e821-473b-7d8a-5d33d09f05862026-05-22Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCd50c8ab6-26f8-4669-89d1-c4d26698159a2026-04-11Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECardinal Health 107, LLCc90fca12-12fb-4cf6-bd6f-83bc0d95df812026-04-07Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEEugia US LLC5ae53725-1abb-4122-9c85-f26c2c31566c2025-12-02Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsName fallback
brand name: acetylcysteine
generic name: ACETYLCYSTEINE
ACETADOTEACETYLCYSTEINECumberland Pharmaceuticals Inc.472f158a-5ab9-4308-8e49-1116e6ea3d392025-04-30Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEAmerican Regent, Inc.f56b4087-db48-4fd7-84ec-9c927962b8052024-12-17Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC75b48fab-cef6-465c-a1e0-d085b3988bc42024-08-15Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCb8d3ed96-d7ee-43f4-986c-a7d04808711a2024-06-13Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEXellia Pharmaceuticals USA LLC3e2e187e-2445-43b1-b66c-b828e2adf0222023-05-31Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8cca4e4c-85a2-d575-e053-2995a90a65992022-10-31Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLCd990ef51-ced2-4359-b99b-092334d2dc9b2022-10-31Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8d81039e-20ef-5144-e053-2a95a90a89fd2022-10-31Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticals2324d60b-4f49-4759-a46e-a06bfce7e8aa2022-04-05Warnings, Adverse reactionsName fallback
brand name: Acetylcysteine
generic name: ACETYLCYSTEINE
ACETYLCYSTEINEACETYLCYSTEINEIndoco Remedies Limited6588c28d-0515-4cdf-99d3-c4ad3fd0976c2022-03-01Warnings, Adverse reactionsName fallback
brand name: ACETYLCYSTEINE
generic name: ACETYLCYSTEINE

Reported adverse events (FAERS/openFDA)#

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