FDA.reportPublic FDA data

NeoTuss S/F

Product NDC
12539-555
11-digit product format
125390555
Labeler code
12539
Product ID
12539-555_463c3e8f-7445-efdd-e063-6394a90a660b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-28
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
200; 30 mg/5mL; mg/5mL
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

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
NeoTuss S/F
Brand name suffix
Grape-Menthol Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f3df82c-1926-5238-e063-6294a90a7bbfAvailable 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12539-555-01NeoTuss S/FGrape-Menthol Flavor30 mL in 1 BOTTLELIQUID302
12539-555-16NeoTuss S/FGrape-Menthol Flavor474 mL in 1 BOTTLELIQUID4742

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12539-555-16ML - Milliliter12539-55550d9fbb2-fd78-4385-a5fc-7ee9d9b9a05812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12539-555NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]1Current NDC, 1 package rows20250322_2fac3425-32f0-38d6-e063-6394a90a6e7a.zip
12539-555NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]1Current NDC, 1 package rows20250303_2f3df82c-1926-5238-e063-6294a90a7bbf.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 71 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honey Lemon cough dropsMENTHOLWalmart Stores Inc.317bbd33-6087-3af1-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Good Sense Nasal DecongestantPSEUDOEPHEDRINE HCLL. Perrigo Company455b35b4-3969-411b-8036-887615d71e112025-12-21WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147924dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral SolutionPSN2f3df82c-1926-5238-e063-6294a90a7bbf2
1147924dextromethorphan HBr 30 MG / guaiFENesin 200 MG in 5 mL Oral SolutionPSN2fac3425-32f0-38d6-e063-6394a90a6e7a2
1147924dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD2f3df82c-1926-5238-e063-6294a90a7bbf2
1147924dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML Oral SolutionSCD2fac3425-32f0-38d6-e063-6394a90a6e7a2
1147924dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY2f3df82c-1926-5238-e063-6294a90a7bbf2
1147924dextromethorphan hydrobromide 30 MG / guaifenesin 200 MG per 5 ML Oral SolutionSY2fac3425-32f0-38d6-e063-6394a90a6e7a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12539-555-011253905550130 mL in 1 BOTTLE (12539-555-01) 30 ml2025-02-28NoNoCurrent
12539-555-1612539055516474 mL in 1 BOTTLE (12539-555-16) 474 ml2025-03-06NoNoCurrent