FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Product NDC
68788-8361
11-digit product format
687888361
Labeler code
68788
Product ID
68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
MO12
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGSL05Y1MN6, 495W7451VQ
Rxcui995868

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
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8361-1Guaifenesin and Codeine Phosphate118 mL in 1 BOTTLESOLUTION1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8361-1ML - Milliliter68788-8361672e8595-c7e3-4604-b583-ec3d5095c05d12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8361GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240517_f5265ae5-db8e-428d-90e9-5eda6a8a22bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNf5265ae5-db8e-428d-90e9-5eda6a8a22bd3
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDf5265ae5-db8e-428d-90e9-5eda6a8a22bd3
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYf5265ae5-db8e-428d-90e9-5eda6a8a22bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8361-168788836101118 mL in 1 BOTTLE (68788-8361-1) 118 ml2023-02-01NoNoHistorical