FDA.reportPublic FDA data

SUPRESS-PE

Product NDC
52083-056
11-digit product format
520830056
Labeler code
52083
Product ID
52083-056_e99c9cb7-48a2-4115-8c61-4f7a0a9942bf
Type
HUMAN OTC DRUG
Nonproprietary name
Guiafenesin, Phenylephrine HCl
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-14
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
50; 2.5 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUPRESS-PE
Brand name suffix
Pediatric
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN50 mg/mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ, 04JA59TNSJ
Rxcui824600

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-056-012025-04-22C16284748780-12cef2736-b234-d83d-e063-dadaa90ab31fSUPRESS ® PE PEDIATRIC DROPS
52083-056-012025-01-30C16284748780-12cef2736-b234-d83d-e063-dadaa90ab31fSUPRESS ® PE PEDIATRIC DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-056-01SUPRESS-PEPediatric30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-056-01ML - Milliliter52083-05664565411-aea5-49ec-874c-a8d98bf894b212014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
GUAIFENESINACTIVE MOIETY495W7451VQSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
SUCROSEINACTIVE INGREDIENTC151H8M554SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2
WATERINACTIVE INGREDIENT059QF0KO0RSUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-056SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]4Current NDC, Legacy NDC, 1 package rows20250424_a474171d-5c29-4a80-9d37-00613796211a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824600guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSNa474171d-5c29-4a80-9d37-00613796211a4
824600guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCDa474171d-5c29-4a80-9d37-00613796211a4
824600guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral SolutionSYa474171d-5c29-4a80-9d37-00613796211a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-056-015208300560130 mL in 1 BOTTLE, DROPPER (52083-056-01) 30 ml2014-01-140000-00-00NoNoCurrent