G-Xpect PSE

Product NDC
43913-407
11-digit product format
439130407
Labeler code
43913
Product ID
43913-407_689b0cc1-a239-4ead-95be-e59de8951f61
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
McLaren Medical
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-11
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43913-407-162019-11-27C16284748780-19855e2a2-489f-60a7-e053-dbdaa90a05bdG-Xpect PSE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43913-407-16G-Xpect PSE473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
GuaifenesinACTIVE INGREDIENT495W7451VQG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
DextromethorphanACTIVE MOIETY7355X3ROTSG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
GuaifenesinACTIVE MOIETY495W7451VQG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3G-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
SorbitolINACTIVE INGREDIENT506T60A25RG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4G-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1
WaterINACTIVE INGREDIENT059QF0KO0RG-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43913-407G-XPECT PSE (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]1Legacy NDC, 1 package rows20140429_19ca6998-8419-4da1-bd6f-7f4fd7477e47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421983dextromethorphan HBr 10 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN19ca6998-8419-4da1-bd6f-7f4fd7477e471
1421983dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD19ca6998-8419-4da1-bd6f-7f4fd7477e471
1421983dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY19ca6998-8419-4da1-bd6f-7f4fd7477e471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43913-407-1643913040716473 mL in 1 BOTTLE, PLASTIC473 mlHistorical