FDA.reportPublic FDA data

GUAIFENESIN and CODEINE PHOSPHATE

Product NDC
70752-180
11-digit product format
707520180
Labeler code
70752
Product ID
70752-180_09ec7e5f-a353-494b-981d-597276be1d4f
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and CODEINE PHOSPHATE
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-05-23
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; GUAIFENESIN
Active strength
10 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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-180-062025-06-24C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830
70752-180-122025-06-24C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830
70752-180-152025-06-24C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830
70752-180-062025-01-30C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830
70752-180-122025-01-30C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830
70752-180-152025-01-30C16284748780-12cef2736-6554-d83d-e063-dadaa90ab31fc166f149-b130-4e18-842f-d4d0a2988830

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-180-06ML - Milliliter70752-180b267459a-7991-4cc2-bcab-813d8399766b12022-09-12
70752-180-12ML - Milliliter70752-18077a1cf7d-f59b-40c1-a888-5aba599b4ff812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-180GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [QUAGEN PHARMACEUTICALS LLC]2Legacy NDC20220705_c166f149-b130-4e18-842f-d4d0a2988830.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNf4d616c9-9c2c-7fa7-e053-2a95a90ac5d51
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDf4d616c9-9c2c-7fa7-e053-2a95a90ac5d51
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYf4d616c9-9c2c-7fa7-e053-2a95a90ac5d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-180-0670752018006118 mL in 1 BOTTLE (70752-180-06) 118 ml2022-05-230000-00-00NoNoCurrent
70752-180-1270752018012473 mL in 1 BOTTLE (70752-180-12) 473 ml2022-05-230000-00-00NoNoCurrent
70752-180-1570752018015237 mL in 1 BOTTLE (70752-180-15) 237 ml2022-05-230000-00-00NoNoCurrent