childrens pediaclear 8

Generic: pyrilamine maleate

Labeler: gm pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens pediaclear 8
Generic Name pyrilamine maleate
Labeler gm pharmaceuticals, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

pyrilamine maleate 12.5 mg/15mL

Manufacturer
GM Pharmaceuticals, INC

Identifiers & Regulatory

Product NDC 58809-770
Product ID 58809-770_404600cf-672a-ccf7-e063-6394a90a1b51
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-08-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58809770
Hyphenated Format 58809-770

Supplemental Identifiers

RxCUI
2178279 2178281
UPC
0358809770083
UNII
R35D29L3ZA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens pediaclear 8 (source: ndc)
Generic Name pyrilamine maleate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (58809-770-08)
source: ndc

Packages (1)

Ingredients (1)

pyrilamine maleate (12.5 mg/15mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "404600cf-672a-ccf7-e063-6394a90a1b51", "openfda": {"upc": ["0358809770083"], "unii": ["R35D29L3ZA"], "rxcui": ["2178279", "2178281"], "spl_set_id": ["8e524967-d01c-4c93-9198-c42f15fe3fe0"], "manufacturer_name": ["GM Pharmaceuticals, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (58809-770-08)", "package_ndc": "58809-770-08", "marketing_start_date": "20190819"}], "brand_name": "Childrens PediaClear 8", "product_id": "58809-770_404600cf-672a-ccf7-e063-6394a90a1b51", "dosage_form": "LIQUID", "product_ndc": "58809-770", "generic_name": "Pyrilamine Maleate", "labeler_name": "GM Pharmaceuticals, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens PediaClear 8", "active_ingredients": [{"name": "PYRILAMINE MALEATE", "strength": "12.5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190819", "listing_expiration_date": "20261231"}