FDA.reportPublic FDA data

Codeine-Guaifenesin

Product NDC
58657-500
11-digit product format
586570500
Labeler code
58657
Product ID
58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4
Type
HUMAN OTC DRUG
Nonproprietary name
Codeine Phosphate and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-01
Substance
CODEINE PHOSPHATE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
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
Codeine-Guaifenesin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CODEINE PHOSPHATE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GSL05Y1MN6Internal 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
995868Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe126254-6ee6-48c3-965c-96e4276a5314Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58657-500-042020-02-11Codeine-Guaifenesin Oral Solution
58657-500-042020-02-11Codeine-Guaifenesin Oral Solution
58657-500-042020-02-11Codeine-Guaifenesin Oral Solution
58657-500-162020-02-11Codeine-Guaifenesin Oral Solution
58657-500-162020-02-11Codeine-Guaifenesin Oral Solution
58657-500-162020-02-11Codeine-Guaifenesin Oral Solution
58657-500-042020-01-31Codeine-Guaifenesin Oral Solution
58657-500-042020-01-31Codeine-Guaifenesin Oral Solution
58657-500-042020-01-31Codeine-Guaifenesin Oral Solution
58657-500-162020-01-31Codeine-Guaifenesin Oral Solution
58657-500-162020-01-31Codeine-Guaifenesin Oral Solution
58657-500-162020-01-31Codeine-Guaifenesin Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-500-04Codeine-Guaifenesin120 mL in 1 BOTTLESOLUTION12016
58657-500-16Codeine-Guaifenesin473 mL in 1 BOTTLESOLUTION47316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-500-04ML - Milliliter58657-500165585be-2a2d-4c03-b517-ef66f56bcc4a12014-07-02
58657-500-16ML - Milliliter58657-500b91df96f-0171-473c-9a97-463f578234c312014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
GUAIFENESINACTIVE INGREDIENT495W7451VQCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
GUAIFENESINACTIVE MOIETY495W7451VQCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RCODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-500CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC]14Current NDC, Legacy NDC, 2 package rows20241126_fe126254-6ee6-48c3-965c-96e4276a5314.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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN9812056b-736e-40c5-ae60-21dd9221397c100
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9812056b-736e-40c5-ae60-21dd9221397c100
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9812056b-736e-40c5-ae60-21dd9221397c100
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNfe126254-6ee6-48c3-965c-96e4276a531416
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDfe126254-6ee6-48c3-965c-96e4276a531416
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYfe126254-6ee6-48c3-965c-96e4276a531416
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNfdfb2d26-f4e1-4559-9db4-12e28bd916b64
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDfdfb2d26-f4e1-4559-9db4-12e28bd916b64
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYfdfb2d26-f4e1-4559-9db4-12e28bd916b64
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSN9e691264-d48a-6b48-e053-2995a90a93523
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9e691264-d48a-6b48-e053-2995a90a93523
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9e691264-d48a-6b48-e053-2995a90a93523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-500-0458657050004120 mL in 1 BOTTLE (58657-500-04) 120 ml2014-04-010000-00-00NoNoCurrent
58657-500-1658657050016473 mL in 1 BOTTLE (58657-500-16) 473 ml2014-04-010000-00-00NoNoCurrent