FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Product NDC
55154-5791
11-digit product format
551545791
Labeler code
55154
Product ID
55154-5791_d55f1824-b4c7-4965-a730-bc1bb66e9762
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-27
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5791-5Guaifenesin and Codeine Phosphate5 in 1 BAGSOLUTION54
55154-5791-5Guaifenesin and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5791GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20241013_a9130f36-4761-4e6b-a383-eca3db06ea93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNa9130f36-4761-4e6b-a383-eca3db06ea934
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa9130f36-4761-4e6b-a383-eca3db06ea934
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYa9130f36-4761-4e6b-a383-eca3db06ea934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55154-5791-5551545791055 CUP, UNIT-DOSE in 1 BAG (55154-5791-5) / 5 mL in 1 CUP, UNIT-DOSE2023-06-27NoNoCurrent