FDA.reportPublic FDA data

Childrens PediaClear PD

Product NDC
58809-651
11-digit product format
588090651
Labeler code
58809
Product ID
58809-651_40464d7d-2e3f-4c29-e063-6294a90a6dd2
Type
HUMAN OTC DRUG
Nonproprietary name
TRIPROLIDINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
GM Pharmaceuticals, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
Substance
TRIPROLIDINE HYDROCHLORIDE
Active strength
1.25 mg/2mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens PediaClear PD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIPROLIDINE HYDROCHLORIDE1.25 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1428927Internal RxNorm lookup
2179647Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3ede5b7-1b0f-493a-b647-4459affc7e54Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-651-50Childrens PediaClear PD50 mL in 1 BOTTLE, DROPPERLIQUID509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-651-50ML - Milliliter58809-651b3f40ab3-c336-41c2-94b7-110bea7d751b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-651CHILDRENS PEDIACLEAR PD (TRIPROLIDINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]8Current NDC, Legacy NDC, 1 package rows20240315_f3ede5b7-1b0f-493a-b647-4459affc7e54.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 73 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLMarc Glassman, Inc.e916ef86-ca73-42dd-83dc-6033f56d96f22025-12-19WarningsExact identifier
application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Marte243033b-6603-4c3e-a330-e7c7de51f69d2025-12-19WarningsExact identifier
application number: M012
CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart6fa4f913-de83-4175-9dad-0dedab5b69a12025-12-19WarningsExact identifier
application number: M012
Day-Time COLD/FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLDiscount Drug Mart426db906-9aa4-448f-a361-09c1516efc252025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDiscount Drug Martf17385bc-82bb-4183-a4c9-067d8afb37572025-12-19WarningsExact identifier
application number: M012
MAXIUM STRENGTH DM MAXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDiscount Drug Mart9654fdcd-d660-471f-bc5d-aa7dead7a4a82025-12-19WarningsExact identifier
application number: M012
Night Time Multi-Symptom Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEDiscount Drug Mart8148c2b1-f6ec-4597-8e18-a6597cda57052025-12-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGNUVICARE LLC621ba20e-75c5-42fb-9692-7800f764c9782025-12-19WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e2025-12-19WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3df82c-1926-5238-e063-6294a90a7bbf2025-12-18WarningsExact identifier
application number: M012
NeoTuss S/F Grape-Menthol FlavorGUAIFENESIN, DEXTROMETHORPHAN HBRDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fac3425-32f0-38d6-e063-6394a90a6e7a2025-12-18WarningsExact identifier
application number: M012
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
application number: M012
Honey Lemon Flavor Cough DropHONEY LEMON FLAVOR COUGH DROPArmy & Air Force Exchange Service20ac8a20-206c-0024-e063-6394a90a9d062025-12-18WarningsExact identifier
application number: M012
Menthol Flavor Cough DropMENTHOL FLAVOR COUGH DROPArmy & Air Force Exchange Service20ace10f-4257-b20e-e063-6394a90a3c7b2025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2fabd782-14dc-1d1b-e063-6394a90af4282025-12-18WarningsExact identifier
application number: M012
NeoTuss PlusDEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals2f3c6b38-7236-899b-e063-6294a90aabde2025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREEMENTHOLChain Drug Marketing Association, Inc.8f6ee01c-baad-489f-b2fd-0ef506916ee42025-12-18WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLMeijer5baeaff7-172c-187a-e053-2a91aa0ab1652025-12-18WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLMeijer Distribution Inc.3bee752a-4141-1f5b-e054-00144ff8d46c2025-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2179647Pediaclear Childrens PD 1.25 MG in 2 mL Oral SolutionPSNf3ede5b7-1b0f-493a-b647-4459affc7e549
1428927triprolidine HCl 0.625 MG in 1 mL Oral SolutionPSNf3ede5b7-1b0f-493a-b647-4459affc7e549
2179647triprolidine hydrochloride 0.625 MG/ML Oral Solution [Pediaclear Childrens]SBDf3ede5b7-1b0f-493a-b647-4459affc7e549
1428927triprolidine hydrochloride 0.625 MG/ML Oral SolutionSCDf3ede5b7-1b0f-493a-b647-4459affc7e549
2179647Pediaclear Childrens 0.625 MG/ML Oral SolutionSYf3ede5b7-1b0f-493a-b647-4459affc7e549
1428927triprolidine hydrochloride 0.625 MG per 1 ML Oral SolutionSYf3ede5b7-1b0f-493a-b647-4459affc7e549
1428927triprolidine hydrochloride 1.25 MG per 2 ML Oral SolutionSYf3ede5b7-1b0f-493a-b647-4459affc7e549

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-651-505880906515050 mL in 1 BOTTLE, DROPPER (58809-651-50) 50 ml2019-07-010000-00-00NoNoCurrent