FDA.reportPublic FDA data

Guaifenesin 200mg

Product NDC
10135-681
Requested package NDC
10135-681-01
11-digit product format
101350681
Labeler code
10135
Product ID
10135-681_ec9a191d-b1b1-dc58-e053-2995a90a4a18
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10135-68110135-681-01IInactivated by FDA2026-10-12

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10135-68110135-681-01IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-68110135-681-01IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-681-012025-07-29C16284748780-1ba0f9c33-5886-a910-e053-dadaa90a0b85Guaifenesin 200mg
10135-681-012021-02-12C16284748780-1ba0f9c33-5886-a910-e053-dadaa90a0b85Guaifenesin 200mg
10135-681-012021-01-29C16284748780-1ba0f9c33-5886-a910-e053-dadaa90a0b85Guaifenesin 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-681-01Guaifenesin 200mg100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-681-01EA - Each10135-6816b0ba7f5-7ae3-46b9-8304-555b4f8e6a9e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-681GUAIFENESIN 200MG (GUAIFENESIN) TABLET [MARLEX PHARMACEUTICALS INC]5Legacy NDC, 1 package rows20241009_5c04a60e-8a73-48b2-88ec-3b0d4b597412.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197741guaiFENesin 200 MG Oral TabletPSN5c04a60e-8a73-48b2-88ec-3b0d4b5974125
197741guaifenesin 200 MG Oral TabletSCD5c04a60e-8a73-48b2-88ec-3b0d4b5974125
197741guaiFENesin 200 MG Oral TabletPSN45ac210a-8c54-4469-8e10-e6fe52b89cb52
197741guaifenesin 200 MG Oral TabletSCD45ac210a-8c54-4469-8e10-e6fe52b89cb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-681-0110135068101100 TABLET in 1 BOTTLE (10135-681-01) 100 tablet2019-03-010000-00-00NoNoCurrent