FDA.reportPublic FDA data

Application 091009

Type
ANDA
Sponsor
ACTAVIS LABS FL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091009-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03a50c72e98297…

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 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsName fallback
generic name: GUAIFENESIN
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsName fallback
generic name: GUAIFENESIN
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsName fallback
generic name: GUAIFENESIN
good sense mucus erGUAIFENESINL. Perrigo Companydef40c3f-29de-4efc-b1d3-4cb89183aaec2026-09-03WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsName fallback
generic name: GUAIFENESIN
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2026-08-10WarningsName fallback
generic name: GUAIFENESIN
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINRugby Laboratoriesee413595-2687-4c38-84ce-18aac933d8e32026-07-15WarningsName fallback
generic name: GUAIFENESIN
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsName fallback
generic name: GUAIFENESIN
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsName fallback
generic name: GUAIFENESIN
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended ReleaseGUAIFENESINTARGET Corporatione521e8e1-8227-451a-8858-01c26f6e06572026-07-06WarningsName fallback
generic name: GUAIFENESIN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0325Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0113-0325Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0363-0325mucus relief erGuaifenesinWalgreen CompanyANDACurrent
11673-325Up and Up mucus reliefGuaifenesinTarget CorporationANDACurrent
11673-325Up and Up mucus reliefGuaifenesinTarget CorporationANDACurrent
11822-0325mucus reliefGuaifenesinRite Aid CorporationANDACurrent
11822-0325mucus reliefGuaifenesinRite Aid CorporationANDACurrent
21130-086Signature Care Mucus Relief MaxGuaifenesinSafewayANDACurrent
21130-086Signature Care Mucus Relief MaxGuaifenesinSafewayANDACurrent
30142-325mucus er maxGuaifenesinKroger CompanyANDACurrent
36800-325TopCare Mucus ERGuaifenesinTopco Associates LLCANDACurrent
37012-325Mucus ER MaxGuaifenesinShopko Stores Operating Co., LLCANDACurrent
37808-325mucus erGuaifenesinH E BANDACurrent
37808-325mucus erGuaifenesinH E BANDACurrent
41163-325Equaline Mucus ERGuaifenesinSupervalu IncANDACurrent
41250-325Mucus ERGuaifenesinMeijer Distribution IncANDACurrent
41250-672maximum strength mucus reliefGuaifenesinMeijer Distribution IncANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPerrigo New York IncANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPadagis Israel Pharmaceuticals LtdANDACurrent
45802-325Guaifenesin Extended ReleaseGuaifenesinPerrigo New York IncANDACurrent
46122-351Good Neighbor Pharmacy Mucus ERGuaifenesinAmerisource BergenANDACurrent
46122-351Good Neighbor Pharmacy Mucus ERGuaifenesinAmerisource BergenANDACurrent
49035-325Equate Mucus ER MaxGuaifenesinWal-Mart Stores IncANDACurrent
49035-325Equate Mucus ER MaxGuaifenesinWal-Mart Stores IncANDACurrent
49738-325Smart Sense Mucus Relief ERGuaifenesinKmart CorporationANDACurrent
55316-325Healthy Accents Mucus ReliefGuaifenesinDZA Brands LLCANDACurrent
55910-728DG Health Mucus ERGuaifenesinDolgencorp, LLCANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
59779-948Mucus Extended ReleaseGuaifenesinCVS PharmacyANDACurrent
62011-0299Health Mart Mucus ERGuaifenesinMckessonANDACurrent
62011-0299Health Mart Mucus ERGuaifenesinStrategic Sourcing Services LLCANDACurrent
68196-325Members Mark mucus relief ERGuaifenesinSam's West IncANDACurrent
69256-325Harris Teeter Mucus Relief MaxGuaifenesinHarris Teeter, LLCANDACurrent
70000-0167Leader Mucus ER MaxGuaifenesinCardinal HealthANDACurrent
70000-0167Leader Mucus ER MaxGuaifenesinCardinal HealthANDACurrent
70677-0035sunmark mucus erGuaifenesinStrategic Sourcing Services LLCANDACurrent
70677-0035sunmark mucus erGuaifenesinStrategic Sourcing Services LLCANDACurrent