FDA.reportPublic FDA data

Codeine-Guaifenesin

Product NDC
17856-0273
11-digit product format
178560273
Labeler code
17856
Product ID
17856-0273_ab37ecd7-9f28-420b-9300-d7f801a5926b
Type
HUMAN OTC DRUG
Nonproprietary name
Codeine Phosphate and Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0273IInactivated by FDA2026-10-16
excluded packagepackage17856-027317856-0273-1IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct17856-0273IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-027317856-0273-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
17856-0273-12024-05-08C16284748780-11030e365-660e-111a-e063-dadaa90a10e2Codeine-Guaifenesin
17856-0273-12024-01-30C16284748780-11030e365-660e-111a-e063-dadaa90a10e2Codeine-Guaifenesin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0273-1Codeine-Guaifenesin72 in 1 BOX, UNIT-DOSESOLUTION723
17856-0273-2Codeine-Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0273-1ML - Milliliter17856-0273a0910118-47e5-4f96-9a75-8529d572bf0c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0273CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 2 package rows20240509_e9705358-3522-46b3-a860-afb9141968b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995868codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral SolutionPSNe9705358-3522-46b3-a860-afb9141968b43
995868codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe9705358-3522-46b3-a860-afb9141968b43
995868codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe9705358-3522-46b3-a860-afb9141968b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0273-11785602730172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0273-1) > 5 mL in 1 CUP, UNIT-DOSE (17856-0273-2) 2022-11-220000-00-00NoNoCurrent
17856-0273-2178560273025 mL in 1 CUP, UNIT-DOSE5 mlHistorical