FDA.reportPublic FDA data

NeoTuss Plus

Product NDC
12539-779
11-digit product format
125390779
Labeler code
12539
Product ID
12539-779_463c45eb-d68e-f00f-e063-6394a90acc91
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4; 30; 7.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE7.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2167750Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fabd782-14dc-1d1b-e063-6394a90af428Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12539-779-01NeoTuss Plus30 mL in 1 BOTTLELIQUID302
12539-779-16NeoTuss Plus474 mL in 1 BOTTLELIQUID4742

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12539-779-16ML - Milliliter12539-779a0a1b661-0c49-4b6f-b7e1-0697fd98b26812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12539-779NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]1Current NDC, 1 package rows20250322_2fabd782-14dc-1d1b-e063-6394a90af428.zip
12539-779NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS]1Current NDC, 1 package rows20250303_2f3c6b38-7236-899b-e063-6294a90aabde.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 150 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDESafeway838d2f11-2ee4-4081-98c8-b87e79aa47c42024-10-11WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d4def70-480f-f2fa-e053-2995a90a98772024-10-10WarningsExact identifier
application number: M012
MentholCOUGH SUPPRESSANTMcKesson9d5b4ef6-4eb8-41f6-e053-2a95a90a13502024-10-10WarningsExact identifier
application number: M012
Tukol Sugar Free Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINGenomma Lab USA95e0a3eb-5a58-4c8b-a70b-fb0cca1e08412024-10-08WarningsExact identifier
application number: M012
Rompe Pecho CF CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06e96e0c-f21f-e706-e063-6294a90a07802024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.f9f0d020-e031-245e-e053-6294a90addb52024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7ee463-8003-a306-e053-6294a90a82592024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7e4a84-d2c2-65e5-e053-6394a90a0c722024-10-08WarningsExact identifier
application number: M012
Cough DropsCHERRYUnited Natural Foods, Inc.f9f0e853-6997-a49b-e053-6294a90aa4b82024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7fa728-911d-aaf0-e053-6394a90ace312024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f3b84-1e61-eadf-e053-6394a90a9e5c2024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
application number: M012
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
application number: M012
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBryant Ranch Prepack8c25285e-e2cd-4e10-af63-5dce8098b6152024-10-08WarningsExact identifier
application number: M012
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsCOUGH DROPSTarget Corporation Inc.a23ddfa9-19e0-99ee-e053-2a95a90a68562024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY CHERRY COUGH DROPSPerrigo Direct, Inc.fb808dc5-bf63-836c-e053-6294a90a80aa2024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY HONEY LEMONPerrigo Direct Inc.fb898616-d604-b4c3-e053-6294a90a23bf2024-10-07WarningsExact identifier
application number: M012
Natural Herb Cough DropsMENTHOL HERBCVS Pharmacyfcd16063-abca-49a0-e053-6294a90acb262024-10-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN2f3c6b38-7236-899b-e063-6294a90aabde2
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN2fabd782-14dc-1d1b-e063-6394a90af4282
2167750chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 6 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD2f3c6b38-7236-899b-e063-6294a90aabde2
2167750chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 6 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD2fabd782-14dc-1d1b-e063-6394a90af4282
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG per 5 ML Oral SolutionSY2f3c6b38-7236-899b-e063-6294a90aabde2
2167750chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / phenylephrine HCl 7.5 MG per 5 ML Oral SolutionSY2fabd782-14dc-1d1b-e063-6394a90af4282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12539-779-011253907790130 mL in 1 BOTTLE (12539-779-01) 30 ml2025-02-28NoNoCurrent
12539-779-1612539077916474 mL in 1 BOTTLE (12539-779-16) 474 ml2025-03-06NoNoCurrent