FDA.reportPublic FDA data

Application 213420

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213420-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08
A213420-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08

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 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-09-14 22:38:342026-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-08-18 06:07:402026-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…

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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus ReliefMUCUS RELIEFAllegiant Health3ed75cff-ee25-4105-b0a0-afbe5bc93b622024-04-24WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus Relief Maximum StrengthMUCUS RELIEFAllegiant Health3d6c30d7-cd02-44a2-b48e-cd65f2896bfd2024-04-23WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Good Sense Mucus ERGUAIFENESINL. Perrigo Company49de9c3b-9840-4fc2-988f-4361de6aa3c12024-02-21WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 0113-3650
EXPECTORANT GUAIFENESIN EXTENDED-RELEASEGUAIFENESINYET HEALTH GROUP LLCf863ab35-046b-4006-901e-dd290c164acc2024-01-03WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 81179-007
dg health mucus er maxGUAIFENESINDolgencorp Incea8deeb0-d6c0-4cb6-b599-ca938ea223972023-10-05WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 55910-626
Mucus ReliefGUAIFENESINFSA STORE INC.f524479a-2c15-50d9-e053-2995a90a805e2023-05-03WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINWINCO FOODS, LLCf45f43da-b992-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus Relief Maximum StrengthGUAIFENESINWINCO FOODS, LLCf45f43da-b955-2bc8-e053-2995a90a93e02023-04-11WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Crcle Guaifenesin Extended-Release Tablets, 600 mgGUAIFENESIN EXTENDED-RELEASEInnovus Pharmaceuticals, Inc.bba4b91a-bea9-41be-9588-5fb1483c7d102023-04-08WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GUAIFENESINGUAIFENESINSafrel Pharmaceuticals, LLC.e2a3d6cb-5251-b88e-e053-2a95a90a9e302023-03-28WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 71309-461
Betr remedies chest congestion reliefGUAIFENESINLive Betr LLC638390ce-4a25-459c-a475-12e079a1d67f2023-03-20WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GUAIFENESIN - ODAAT 1200 MGGUAIFENESINLODAAT LLCf61d3ae0-11eb-2a82-e053-2995a90a95da2023-03-04WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Betr chest congestion reliefGUAIFENESINLive Betr LLCadd40484-8e77-464b-939c-a3c620b993cb2023-02-22WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 80267-002
Mucus ReliefGUAIFENESINFSA STORE INC.ec6b5d2f-6568-08d8-e053-2995a90a4d4b2023-01-12WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 81522-203
Mucus ReliefGUAIFENESINDemoulas Super Markets, Ince8948cbe-1eca-490d-e053-2995a90a6ba12022-10-03WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 53942-203
Mucus Relief Maximum StrengthGUAIFENESINDemoulas Super Markets, Ince8948cbe-1ecc-490d-e053-2995a90a6ba12022-10-03WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 53942-204
berkley and jensen mucus reliefGUAIFENESINBJWC433588eb-18ad-473f-9527-4947a143824e2022-04-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 68391-000
basic care mucus er maxGUAIFENESINAmazon.com Services LLC9ab3d192-0fd4-48fd-95ea-3182c63a73272022-04-12WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
ndc (product): 72288-650

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 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-3650Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0113-3650Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0113-3650Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
0113-3650Good Sense Mucus ERGuaifenesinL. Perrigo CompanyANDACurrent
41250-654mucus reliefguaifenesinMeijer Distribution IncANDACurrent
41250-654mucus reliefguaifenesinMeijer Distribution IncANDACurrent
46122-683good neighbor pharmacy mucus erGuaifenesinAmerisource BergenANDACurrent
46122-683good neighbor pharmacy mucus erGuaifenesinAmerisource BergenANDACurrent
53942-203Mucus ReliefGuaifenesinDemoulas Super Markets, IncANDACurrent
53942-204Mucus ReliefGuaifenesinDemoulas Super Markets, IncANDACurrent
55681-301MUCUS RELIEFGUAIFENESINTWIN MED LLCANDACurrent
55910-626dg health mucus er maxGuaifenesinDolgencorp IncANDACurrent
62207-569GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-569GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-569GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-569GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-570GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-570GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-570GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-697Guaifenesin Extended-Release Tablets, 600mgGuaifenesin Extended-ReleaseGranules India LtdANDACurrent
62207-698Guaifensin Extended-Release Tablets, 1200 mgGuaifensin Extended-ReleaseGranules India LtdANDACurrent
62207-839GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-839GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-839GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-840GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-840GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
62207-840GUAIFENESINGUAIFENESINGranules India LtdANDACurrent
63868-148Maximum Strength Mucus ReliefGuaifenesinCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-14912 Hour Mucus ReliefGuaifenesinCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
68391-000berkley and jensen mucus reliefGuaifenesinBJWCANDACurrent
68391-000berkley and jensen mucus reliefGuaifenesinBJWCANDACurrent
69842-335GuaifenesinGuaifenesinCVS PHARMACY, INCANDACurrent
69848-017GuaifenesinGuaifenesinGRANULES USA, INC.ANDACurrent
69848-018GuaifenesinGuaifenesinGRANULES USA, INC.ANDACurrent
70010-199GUAIFENESINGUAIFENESINGRANULES PHARMACEUTICALS INC.ANDACurrent
71141-168Mucus ReliefGuaifenesinLIDL US LLCANDACurrent
71309-460Safrel Mucus ReliefGuaifenesinSafrel Pharmaceuticals, LLC.ANDACurrent
71309-461GUAIFENESINGUAIFENESINSafrel Pharmaceuticals, LLC.ANDACurrent
72288-650basic care mucus er maxGuaifenesinAmazon.com Services LLCANDACurrent
72288-650basic care mucus er maxGuaifenesinAmazon.com Services LLCANDACurrent
72559-013Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-013Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-013Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-017Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-017Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-017Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
72559-017Curist Mucus ReliefGuaifenesinLittle Pharma, Inc.ANDACurrent
73581-401MUCUS RELIEFGUAIFENESINYYBA CORPANDACurrent
73581-402MUCUS RELIEFGUAIFENESINYYBA CORPANDACurrent
80267-002betr chest congestion reliefGuaifenesinLive Betr LLCANDACurrent
81179-007EXPECTORANT GUAIFENESIN EXTENDED-RELEASEGUAIFENESINYET HEALTH GROUP LLCANDACurrent
81179-007EXPECTORANT GUAIFENESIN EXTENDED-RELEASEGUAIFENESINYET HEALTH GROUP LLCANDACurrent
81179-007EXPECTORANT GUAIFENESIN EXTENDED-RELEASEGUAIFENESINYET HEALTH GROUP LLCANDACurrent
81179-007EXPECTORANT GUAIFENESIN EXTENDED-RELEASEGUAIFENESINYET HEALTH GROUP LLCANDACurrent
81522-203Mucus ReliefGuaifenesinFSA STORE INC.ANDACurrent