FDA.reportPublic FDA data

Maxi-Tuss PE

Product NDC
58605-306
11-digit product format
586050306
Labeler code
58605
Product ID
58605-306_f794eb3e-905e-4ce1-8a9d-6436065096d9
Type
HUMAN OTC DRUG
Nonproprietary name
BROMPHENIRAMINE MALEATE 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
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58605-306-162022-01-28C16284748780-1d6a99b39-8ffd-a426-e053-dadaa90af4c2Maxi-Tuss PE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58605-306-16Maxi-Tuss PE473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58605-306-16ML - Milliliter58605-306c49ef842-3102-4518-85fe-1abcab1a730512020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58605-306MAXI-TUSS PE (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [MCR AMERICAN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200801_cd18a0d2-a5ff-4261-be1f-1d0e3774a06a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1357013brompheniramine maleate 2 MG / phenylephrine HCl 5 MG in 5 mL Oral SyrupPSNcd18a0d2-a5ff-4261-be1f-1d0e3774a06a1
1357013brompheniramine maleate 0.4 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDcd18a0d2-a5ff-4261-be1f-1d0e3774a06a1
1357013brompheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG per 5 ML Oral SyrupSYcd18a0d2-a5ff-4261-be1f-1d0e3774a06a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58605-306-1658605030616473 mL in 1 BOTTLE, PLASTIC (58605-306-16) 473 ml2020-08-010000-00-00NoNoCurrent