FDA.reportPublic FDA data

Mucus Relief

Product NDC
53942-203
Requested package NDC
53942-203-02
11-digit product format
539420203
Labeler code
53942
Product ID
53942-203_ea23a104-e734-9a62-e053-2a95a90a9cb2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
ANDA213420
Marketing category
ANDA
Marketing start
2022-10-01
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2021-12-28 21:50 UTC2021-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0887673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
636522Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8948cbe-1eca-490d-e053-2995a90a6ba1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-203-02Mucus Relief20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE202
53942-203-02Mucus Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-203MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [DEMOULAS SUPER MARKETS, INC]2Current NDC, Legacy NDC, 2 package rows20221004_e8948cbe-1eca-490d-e053-2995a90a6ba1.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 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Mucus ERGUAIFENESINTopco Associates LLC916de841-b1eb-4f00-9e25-1d2e4ab0c6e92026-06-18WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Dr. Simi Mucus ReliefGUAIFENESINFarmacias De Similares TX LLC4ef7dae3-9081-bc3b-e063-6294a90a9a752026-04-08WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mgGUAIFENESINTWIN MED LLCd9d13c67-51a1-aa79-e053-2995a90abdbb2026-03-26WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
good neighbor pharmacy mucus erGUAIFENESINAmerisource Bergen41b4a15d-f5a7-4c45-b950-0aa6b093be1c2026-03-12WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-03-03WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GUAIFENESINGUAIFENESINProficient Rx LP28b31f37-6896-40f5-8f3a-60c93c5c12782026-02-01WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINHYVEE INC462cb425-1fdf-0623-e063-6294a90abd182026-01-13WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINGRANULES USA, INC.a62d427e-f339-f225-e053-2a95a90ab3872025-12-22WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINGRANULES USA, INC.a62e2045-8ec2-1771-e053-2995a90a03b42025-12-22WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINPioneer Life Sciences, LLCbe8ec612-41a8-479e-a889-7e09f2d27c102025-12-22WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINSafeway, Incf32e5b0f-1fd9-9b33-e053-2995a90a81032025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINTARGET CORPORATION09957814-61e2-4488-e063-6294a90a22012025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINTARGET CORPORATION0a0aa190-8dc7-f9cc-e063-6394a90a60782025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINSAM'S WEST INC00c40e3b-6962-dfb4-e063-6294a90afec62025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINCVS PHARMACY, INCbdaf7359-8698-87d6-e053-2a95a90ada282025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINWalgreensfd913bc8-9e1e-3a63-e053-6394a90a34fb2025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
GuaifenesinGUAIFENESINWalgreensfd91621b-c969-8851-e053-6294a90ad8b22025-12-19WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINNUVICARE LLCa6608a39-2023-4953-a7c3-1764a6b215a32025-12-16WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINNUVICARE LLCd6734345-29a1-4356-a063-ff37ed4fbe9a2025-12-05WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420
Mucus ReliefGUAIFENESINPioneer Life Sciences, LLCd635b228-a51f-42d9-885c-3cd566fd352b2025-12-04WarningsExact identifier
application applno (ANDA): 213420
application number: ANDA213420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe8948cbe-1eca-490d-e053-2995a90a6ba12
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe8948cbe-1eca-490d-e053-2995a90a6ba12
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe8948cbe-1eca-490d-e053-2995a90a6ba12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-203-02539420203021 BLISTER PACK in 1 CARTON (53942-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-10-010000-00-00NoNoCurrent