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
Ingredient	Strength
TRIPROLIDINE HYDROCHLORIDE	1.25 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YAN7R5L890	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1428927	Internal RxNorm lookup
2179647	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
f3ede5b7-1b0f-493a-b647-4459affc7e54	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58809-651-50	Childrens PediaClear PD	50 mL in 1 BOTTLE, DROPPER	LIQUID	50		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58809-651-50	ML - Milliliter	58809-651	b3f40ab3-c336-41c2-94b7-110bea7d751b	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58809-651	CHILDRENS PEDIACLEAR PD (TRIPROLIDINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC]	8	Current NDC, Legacy NDC, 1 package rows	20240315_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 171 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	Warnings	Exact identifier application number: M012
Childrens Cough Mucus Relief	DEXTROMETHORPHANN HBR, GUAIFENESIN	Discount Drug Mart	2c27aca4-e1e2-419a-84c4-857718ca49da	2023-12-29	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	de2b2e34-62a5-451f-ab68-531d1c9d4d82	2023-12-29	Warnings	Exact identifier application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	d2b016ee-5329-45bf-9d71-d626204169cf	2023-12-29	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2179647	Pediaclear Childrens PD 1.25 MG in 2 mL Oral Solution	PSN	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
1428927	triprolidine HCl 0.625 MG in 1 mL Oral Solution	PSN	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
2179647	triprolidine hydrochloride 0.625 MG/ML Oral Solution [Pediaclear Childrens]	SBD	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
1428927	triprolidine hydrochloride 0.625 MG/ML Oral Solution	SCD	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
2179647	Pediaclear Childrens 0.625 MG/ML Oral Solution	SY	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
1428927	triprolidine hydrochloride 0.625 MG per 1 ML Oral Solution	SY	f3ede5b7-1b0f-493a-b647-4459affc7e54	9
1428927	triprolidine hydrochloride 1.25 MG per 2 ML Oral Solution	SY	f3ede5b7-1b0f-493a-b647-4459affc7e54	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58809-651-50	58809065150	50 mL in 1 BOTTLE, DROPPER (58809-651-50)	50 ml	2019-07-01	0000-00-00	No	No	Current