FDA.reportPublic FDA data

Childrens PediaClear 8

Product NDC
58809-770
11-digit product format
588090770
Labeler code
58809
Product ID
58809-770_404600cf-672a-ccf7-e063-6394a90a1b51
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrilamine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
GM Pharmaceuticals, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-19
Substance
PYRILAMINE MALEATE
Active strength
12.5 mg/15mL
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 8
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRILAMINE MALEATE12.5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2178279Internal RxNorm lookup
2178281Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e524967-d01c-4c93-9198-c42f15fe3fe0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-770-08Childrens PediaClear 8237 mL in 1 BOTTLELIQUID2379

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58809-770-08ML - Milliliter58809-770aa10cc27-d748-4478-83a6-231f5b1849f212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-770CHILDRENS PEDIACLEAR 8 (PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC]8Current NDC, Legacy NDC, 1 package rows20241009_8e524967-d01c-4c93-9198-c42f15fe3fe0.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 22 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyd1657403-b953-4db1-9a86-343e9e769a1a2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company04dc3835-64be-d9e4-e063-6394a90a85992026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company1a01b294-a5ee-ab35-e063-6394a90a4a1a2026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9b3bbb-4494-065d-e063-6294a90afcd22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids ALLERGYDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2f9a6d65-f849-af0a-e063-6394a90ae4352026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company1a01d4f7-37ed-bb92-e063-6294a90a208c2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company326ed27d-cbfa-5513-e063-6394a90a41bf2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil Kids and Vicks NyQuil Kids COLD and COUGH plus FEVERACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company2d430264-074d-fb22-e063-6294a90a57f62026-06-22WarningsExact identifier
application number: M012
DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINThe Procter & Gamble Manufacturing Companyef6e8503-d268-291b-e053-2995a90aec8f2026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4147ff00-8e21-7335-e054-00144ff88e882026-06-22WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN51021c69-d92b-0504-e063-6294a90a94e72026-06-22WarningsExact identifier
application number: M012
Vicks NyQuil SINUS PAIN and HEADACHEACETAMINOPHEN, DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Company4c4ca296-ea6c-1f19-e063-6294a90a81612026-06-22WarningsExact identifier
application number: M012
Vicks DayQuil and Vicks NyQuil INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Company32bea3dc-9889-22dd-e063-6394a90afa1b2026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
Sinus and Congestion Non-DrowsyPSEUDOEPHEDRINE HCLWal-Mart Stores Inccbdac7ad-3904-4a85-91a9-863f6f06503d2026-06-22WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178281PediaClear 12.5 MG in 15 mL Oral SolutionPSN8e524967-d01c-4c93-9198-c42f15fe3fe09
2178279pyrilamine maleate 12.5 MG in 15 mL Oral SolutionPSN8e524967-d01c-4c93-9198-c42f15fe3fe09
2178281pyrilamine maleate 0.833 MG/ML Oral Solution [Pediaclear]SBD8e524967-d01c-4c93-9198-c42f15fe3fe09
2178279pyrilamine maleate 0.833 MG/ML Oral SolutionSCD8e524967-d01c-4c93-9198-c42f15fe3fe09
2178281Pediaclear 0.833 MG/ML Oral SolutionSY8e524967-d01c-4c93-9198-c42f15fe3fe09
2178281Pediaclear 12.5 MG per 15 mL Oral SolutionSY8e524967-d01c-4c93-9198-c42f15fe3fe09
2178279pyrilamine maleate 12.5 MG per 15 mL Oral SolutionSY8e524967-d01c-4c93-9198-c42f15fe3fe09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-770-0858809077008237 mL in 1 BOTTLE (58809-770-08) 237 ml2019-08-190000-00-00NoNoCurrent