FDA.reportPublic FDA data

Maximum strength Tussnex FM DM Max

Product NDC
53041-628
11-digit product format
530410628
Labeler code
53041
Product ID
53041-628_e39a2556-4a5b-4306-b2d1-b93b75d39b06
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maximum strength Tussnex FM DM Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bae53e3-9661-4bc6-9fcc-da7fa131b034Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-628-58Maximum strength Tussnex FM DM Max177 mL in 1 BOTTLELIQUID1774

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
GUAIFENESINACTIVE MOIETY495W7451VQMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-628MAXIMUM STRENGTH TUSSNEX FM DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GUARDIAN DRUG COMPANY]4Current NDC, Legacy NDC, 1 package rows20241222_0bae53e3-9661-4bc6-9fcc-da7fa131b034.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 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-20WarningsExact identifier
application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY, INCfe12f3bd-3237-42d1-aec5-c831b96371752026-08-19WarningsExact identifier
application number: M012
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
application number: M012
CVS Long Acting CoughDEXTROMETHORPHAN HBRCVS PHARMACY, INC31a7c0e2-af1c-45dd-8a93-e0879cae60052026-08-19WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLCb3baf939-a9fd-47ac-9bc7-68435e32ea1e2026-08-19WarningsExact identifier
application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY5151127a-4d09-413a-a08b-f76fb77e11882026-08-19WarningsExact identifier
application number: M012
CVS DT and NT Combo Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY360c8c62-0945-4031-b291-d40c4270b9402026-08-19WarningsExact identifier
application number: M012
equate childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.24758ab0-ba08-4b4a-9861-449612bdb89c2026-08-19WarningsExact identifier
application number: M012
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsExact identifier
application number: M012
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCVS PHARMACY4490a7e1-d5b9-459c-8751-c244868079812026-08-19WarningsExact identifier
application number: M012
CVS DayTime and NightTime Value Pack Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATECVS PHARMACY4c813cd5-2c97-4fc3-926c-1a0396551a312026-08-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN0bae53e3-9661-4bc6-9fcc-da7fa131b0344
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD0bae53e3-9661-4bc6-9fcc-da7fa131b0344
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY0bae53e3-9661-4bc6-9fcc-da7fa131b0344
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY0bae53e3-9661-4bc6-9fcc-da7fa131b0344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-628-5853041062858177 mL in 1 BOTTLE (53041-628-58) 177 ml2012-05-010000-00-00NoNoCurrent