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
Ingredient	Strength
PYRILAMINE MALEATE	12.5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R35D29L3ZA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8e524967-d01c-4c93-9198-c42f15fe3fe0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-770-08	Childrens PediaClear 8	237 mL in 1 BOTTLE	LIQUID	237		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-770-08	ML - Milliliter	58809-770	aa10cc27-d748-4478-83a6-231f5b1849f2	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-770	CHILDRENS PEDIACLEAR 8 (PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC]	8	Current NDC, Legacy NDC, 1 package rows	20241009_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 92 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGH	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	TARGET CORPORATION	05ac2a40-5eee-4013-b55b-6e370a28b21c	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENs COLD and COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	eb912834-1b14-484d-90f7-a8deb52c0d4e	2025-11-05	Warnings	Exact identifier application number: M012
UP and UP Daytime Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	a2d99bc8-7295-4922-acff-0cb02c91273c	2025-11-05	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	AMERISOURCE BERGEN	c1843f1a-ae5b-0fdf-e053-2995a90aae38	2025-11-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4754363d-e163-42e0-a65d-1c4bac24f6c9	2025-11-05	Warnings	Exact identifier application number: M012
Day Time Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Safeway, Inc.	76d62892-615d-4744-95aa-3be1207a0e57	2025-11-05	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Safeway, Inc.	6fefff08-13b0-47eb-aa32-8d7e4deeae7b	2025-11-05	Warnings	Exact identifier application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ct	MENTHOL	R.L. ALBERT & SON, INC	165a8efa-2b03-4329-99fa-3233f0af7d08	2025-11-04	Warnings	Exact identifier application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ct	MENTHOL	R.L. ALBERT & SON, INC	f9ea46fc-0b04-444e-95fc-09aff7e7978a	2025-11-04	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40413cdb-68ac-70e1-e063-6394a90a9217	2025-11-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	73fec783-1594-447b-b059-49ea9dbb5bee	2025-11-04	Warnings	Exact identifier application number: M012
Texaclear Fast Acting Allergy Relief	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	17a2f643-fa98-21ee-e054-00144ff88e88	2025-11-03	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e618bc7-0f51-e586-e063-6294a90afe37	2025-11-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e61b5b3-ad15-01bf-e063-6394a90a6ec3	2025-11-03	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	409540c0-1bab-9969-e063-6394a90a47c1	2025-11-03	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e60b340-bd60-9318-e063-6294a90ad079	2025-11-03	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e60e32f-3e5f-b775-e063-6294a90a097d	2025-11-03	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	3e614265-b35a-5d01-e063-6294a90aad85	2025-11-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e60b0ed-889d-0f17-e063-6394a90a4694	2025-11-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2178281	PediaClear 12.5 MG in 15 mL Oral Solution	PSN	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178279	pyrilamine maleate 12.5 MG in 15 mL Oral Solution	PSN	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178281	pyrilamine maleate 0.833 MG/ML Oral Solution [Pediaclear]	SBD	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178279	pyrilamine maleate 0.833 MG/ML Oral Solution	SCD	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178281	Pediaclear 0.833 MG/ML Oral Solution	SY	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178281	Pediaclear 12.5 MG per 15 mL Oral Solution	SY	8e524967-d01c-4c93-9198-c42f15fe3fe0	9
2178279	pyrilamine maleate 12.5 MG per 15 mL Oral Solution	SY	8e524967-d01c-4c93-9198-c42f15fe3fe0	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-770-08	58809077008	237 mL in 1 BOTTLE (58809-770-08)	237 ml	2019-08-19	0000-00-00	No	No	Current