MUCUS RELIEF

Product NDC
71335-1035
11-digit product format
713351035
Labeler code
71335
Product ID
71335-1035_752e84a6-9670-4527-aacd-4ec57bc0c3c7
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-01
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 2 · 72 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1035-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1035-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1035-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1035-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1035-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1035-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1035-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1035-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1035-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1035-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1035-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1035-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1035-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1035-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1035-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1035-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1035-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1035-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1035-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1035-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1035-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1035-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1035-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1035-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1035-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1035-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1035-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1035-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1035-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1035-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1035-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1035-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1035-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1035-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1035-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1035-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1035-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1035-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1035-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1035-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1035-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1035-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1035-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1035-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1035-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1035-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1035-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1035-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1035-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1035-3ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MUCUS RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 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
359601Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ed5611f-4e1d-4f71-b430-a2a949bf7fe5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1035-1MUCUS RELIEF30 in 1 BOTTLETABLET308
71335-1035-2MUCUS RELIEF20 in 1 BOTTLETABLET208
71335-1035-3MUCUS RELIEF50 in 1 BOTTLETABLET508
71335-1035-4MUCUS RELIEF60 in 1 BOTTLETABLET608
71335-1035-5MUCUS RELIEF40 in 1 BOTTLETABLET408

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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSN9ed5611f-4e1d-4f71-b430-a2a949bf7fe58
359601guaifenesin 400 MG Oral TabletSCD9ed5611f-4e1d-4f71-b430-a2a949bf7fe58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1035-17133510350130 TABLET in 1 BOTTLE (71335-1035-1) 30 tablet2019-02-230000-00-00NoNoCurrent
71335-1035-27133510350220 TABLET in 1 BOTTLE (71335-1035-2) 20 tablet2019-02-230000-00-00NoNoCurrent
71335-1035-37133510350350 TABLET in 1 BOTTLE (71335-1035-3) 50 tablet2019-02-230000-00-00NoNoCurrent
71335-1035-47133510350460 TABLET in 1 BOTTLE (71335-1035-4) 60 tablet2019-02-230000-00-00NoNoCurrent
71335-1035-57133510350540 TABLET in 1 BOTTLE (71335-1035-5) 40 tablet2019-02-230000-00-00NoNoCurrent