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 5 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH464534ee-15f8-3af8-e063-6394a90a3f182026-08-24WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact 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