FDA.reportPublic FDA data

Maxi-Tuss PE Max

Product NDC
58605-315
11-digit product format
586050315
Labeler code
58605
Product ID
58605-315_7118d007-579e-4983-9682-f5bf555605cf
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN and Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
MCR American Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-01
Marketing end
0000-00-00
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
58605-315-162022-01-28C16284748780-1d6a99b39-9009-a426-e053-dadaa90af4c2Maxi-Tuss PE Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-315-16Maxi-Tuss PE Max473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-315-16ML - Milliliter58605-315d391e3fb-9e1c-44fe-a3b6-894c50c6595e12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-315MAXI-TUSS PE MAX (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200801_d7505224-87e6-4ce5-a76d-e7637b3f315c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358627guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSNd7505224-87e6-4ce5-a76d-e7637b3f315c1
1358627guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDd7505224-87e6-4ce5-a76d-e7637b3f315c1
1358627guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SolutionSYd7505224-87e6-4ce5-a76d-e7637b3f315c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58605-315-1658605031516473 mL in 1 BOTTLE, PLASTIC (58605-315-16) 473 ml2020-08-010000-00-00NoNoCurrent