FDA.reportPublic FDA data

NEOGEN-D

Product NDC
52083-699
11-digit product format
520830699
Labeler code
52083
Product ID
52083-699_d07bcab7-dbac-4af0-8f6a-cb9a86871775
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form
SOLUTION
Route
ORAL
Labeler
Kramer Novis
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-10-10
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
30 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-699-162020-01-31C16284748780-19d75b9d0-f00d-f424-e053-dadaa90a57ceNEOGEN ® -D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-699-16NEOGEN-D473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-699NEOGEN-D (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]1Legacy NDC, 1 package rows20181207_98b1e8bc-63a9-40c5-b952-5acab3122d62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000502dextromethorphan HBr 30 MG / guaiFENesin 200 MG / phenylephrine HCl 7.5 MG in 5 mL Oral SolutionPSN98b1e8bc-63a9-40c5-b952-5acab3122d621
1000502dextromethorphan hydrobromide 6 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1.5 MG/ML Oral SolutionSCD98b1e8bc-63a9-40c5-b952-5acab3122d621
1000502dextromethorphan HBr 30 MG / guaifenesin 200 MG / phenylephrine HCl 7.5 MG per 5 ML Oral SolutionSY98b1e8bc-63a9-40c5-b952-5acab3122d621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52083-699-1652083069916473 mL in 1 BOTTLE, PLASTIC473 mlHistorical