FDA.reportPublic FDA data

Goyescas 7 Syrups Original

Product NDC
11856-0001
11-digit product format
118560001
Labeler code
11856
Product ID
11856-0001_2205bf29-d23d-4ec2-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin, Phenylephrine
Dosage form
LIQUID
Route
ORAL
Labeler
GOYESCAS OF FLA
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1958-08-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11856-0001IInactivated by FDA2026-07-31
excluded packagepackage11856-000111856-0001-1IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxymethazoline HCLOXYMETHAZOLINE HCLPreferred Pharmaceuticals Inc.cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c42026-07-29WarningsExact identifier
Pi Yuan ChinNAPHAZOLINE HYDROCHLORIDEInternational Nature Nutraceuticalse7aedab9-da4c-4494-a896-1e6ed2a956fe2025-12-27WarningsExact identifier
Childrens Multi-symptom Cold DaytimeDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.1768677d-96ec-f9f7-e063-6394a90a4ef42025-11-21WarningsExact identifier
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPreferred Pharmaceuticals Inc.5b2fd5ce-56ab-491a-81b9-44e35a5d23162025-09-17WarningsExact identifier
TussinGUAIFENESINStrategic Sourcing Services188f3c82-b4bc-42a5-8068-c2fa0c2ac3442025-01-08WarningsExact identifier
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
QCH Adult Tussin DM 542DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17caffa4-a264-7f3e-e063-6394a90ac4192024-05-08WarningsExact identifier
QCH Adult Tussin DM Sugar free 545DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.17cb91f0-32ec-9e0f-e063-6394a90a05092024-05-08WarningsExact identifier
QCH Adult Tussin 541GUAIFENESINChain Drug Marketing Association Inc.b487f4af-ad0c-4f18-9a6b-7fd386b3f46c2024-05-02WarningsExact identifier
QCH Maximum Strength Mucus Relief DM 628DEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association Inc.a2795bf5-34c6-4de6-b9e5-53a23d18e3572024-04-26WarningsExact identifier
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINFamily Dollar Services, Inc.07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e32024-04-17WarningsExact identifier
Quality Choice Dye Free Cherry Childrens Allergy ReliefDIPHENHYDRAMINE HCLChain Drug Marketing Association Inc.302ca7b5-f65c-4187-bbd6-f482be6e63c12024-03-18WarningsExact identifier
MUCUS RELIEF DMDEXTROMETHORPHAN HBR/GUAIFENESINKROGER COMPANY813baf42-edb0-33a9-e053-2a91aa0a85992019-05-21WarningsExact identifier
MUCUS RELIEFGUAIFENESINKROGER COMPANY813b1db2-a177-77c6-e053-2a91aa0ac73b2019-05-15WarningsExact identifier
Discount Drug Mart Value Vapor SteamCAMPHOR (SYNTHETIC)Drug Mart87230c40-ea77-0f3a-e053-2991aa0ae7842019-04-22WarningsExact identifier
Best Choice Vapor SteamCAMPHOR (SYNTHETIC)Valu merchandiser86bb3a80-c675-d478-e053-2a91aa0a8c272019-04-17WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.c7cdbf2f-4841-4a7a-9056-6a741abc31332019-01-19WarningsExact identifier
Assured Vaporizing Chest RubCAMPHOR AND EUCALYPTUS OIL AND MENTHOLGreenbrier International, Inc.b8f0c61e-83b0-4835-b950-2c5dcce5cf172019-01-19WarningsExact identifier
Pressure Pain Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association1e54ecb3-c3c3-477a-8725-23f24e77a44b2018-12-31WarningsExact identifier
Allergy TimeCHLORPHENIRAMINE MALEATETime Cap Labs Inc588c424a-8dd6-417e-8f76-2ce0cc2b0c122018-12-17WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this prduct do not use more than directed do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur use of this container by more than one person may spread infection

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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11856-0001-12020-01-31C16284748780-19d75b9d1-034b-f424-e053-dadaa90a57ce2205bf29-d23c-4ec2-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11856-0001-1Goyescas 7 Syrups OriginalCough and Cold1 in 1 BOXLIQUID11
11856-0001-1Goyescas 7 Syrups OriginalCough and Cold177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11856-0001GOYESCAS 7 SYRUPS ORIGINAL COUGH AND COLD (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [GOYESCAS OF FLA]1Legacy NDC, 2 package rows20151212_2205bf29-d23c-4ec2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726414dextromethorphan HBr 10 MG / guaiFENesin 50 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN2205bf29-d23c-4ec2-e054-00144ff88e881
1726414dextromethorphan hydrobromide 2 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD2205bf29-d23c-4ec2-e054-00144ff88e881
1726414dextromethorphan hydrobromide 10 MG / guaifenesin 50 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSY2205bf29-d23c-4ec2-e054-00144ff88e881
1726414dextromethorphan hydrobromide 30 MG / guaifenesin 150 MG / phenylephrine hydrochloride 15 MG per 15 ML Oral SolutionSY2205bf29-d23c-4ec2-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11856-0001-1118560001011 in 1 BOXHistorical