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 122 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLThe Kroger COf6da2e02-42c7-1ede-e053-6394a90aff5f2025-02-09WarningsExact identifier
application number: M012
MUCOSA DMGUAIFENESIN DEXTROMETHORPHANTIME CAP LABORATORIES, INC.62c1f4aa-6571-414c-9a58-31e107b7db972025-02-08WarningsExact identifier
application number: M012
Childrens Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.2d95d5a4-34dc-e195-e063-6394a90a39da2025-02-07WarningsExact identifier
application number: M012
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC5d56ccd2-1c28-4750-9454-44809091ad2f2025-02-05WarningsExact identifier
application number: M012
SanaTos Mucus Relief Cold ToddlersDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC60672feb-1421-651e-e053-2a91aa0af41d2025-02-04WarningsExact identifier
application number: M012
SofSkin Vaporizing Chest Rub and Cough SuppressantCAMPHOR, MENTHOL, EUCALYPTUS OILViny Health and Beauty Inc34626cf5-64fc-15c0-e063-6294a90aa3102025-02-04WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS PHARMACY, INC17922df7-7867-4300-bd99-55aee7b606062025-02-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYCVS Healthf4b8ff54-47b5-4d18-bf4e-b101abb22a242025-02-03WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepackf40bfdfc-1cb4-4604-9790-fb8d1d5173c62025-01-31WarningsExact identifier
application number: M012
NIGHTIME COLD AND FLUNIGHTIME COLD AND FLUTARGET CORP9dee9b92-eac9-b07d-e053-2995a90a06022025-01-31WarningsExact identifier
application number: M012
Rugby Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINBryant Ranch Prepack7b23faa9-40c8-4cea-b9fb-487cce2664af2025-01-31WarningsExact identifier
application number: M012
BENADRYL AllergyDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC224ba2a3-1a93-29c8-e063-6394a90a9bef2025-01-30WarningsExact identifier
application number: M012
Extra Strength Nite-Time Pain Relief430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLETWALGREENSc25cff5a-93f5-62aa-e053-2a95a90aa7b42025-01-30WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALGREENSdbf5c814-4e69-13ac-e053-2a95a90a49a32025-01-30WarningsExact identifier
application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWALGREENSf3770976-de73-52b8-e053-2995a90aad4f2025-01-30WarningsExact identifier
application number: M012
Dextromethorphan HBr and Guaifenesin Oral SolutionDEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTIONKESIN PHARMA CORPORATION284eae44-81bc-400c-e063-6394a90af4462025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.26c82bc3-5753-4d56-96a4-a3f9c8c267d02025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8095b211-8ae7-44e5-b89a-b7f730e28d512025-01-30WarningsExact identifier
application number: M012
Vapor ShowerMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2cf2f35b-5d59-e3ff-e063-6294a90a9b452025-01-30WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c52025-01-30WarningsExact 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