dr. sana pain and fever for children

Generic: acetaminophen

Labeler: gadal laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dr. sana pain and fever for children
Generic Name acetaminophen
Labeler gadal laboratories, inc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
GADAL Laboratories, Inc

Identifiers & Regulatory

Product NDC 53113-516
Product ID 53113-516_d3ebeaac-ec26-4f27-be5d-739918117f2f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53113516
Hyphenated Format 53113-516

Supplemental Identifiers

RxCUI
307675
UPC
0729545305165
UNII
362O9ITL9D

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 dr. sana pain and fever for children (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (53113-516-06) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

53113-516-06 1 BOTTLE in 1 BOX (53113-516-06) / 180 mL in 1 BOTTLE

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

DR. SANA PAIN AND FEVER FOR Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d3ebeaac-ec26-4f27-be5d-739918117f2f", "openfda": {"upc": ["0729545305165"], "unii": ["362O9ITL9D"], "rxcui": ["307675"], "spl_set_id": ["8a22a5ba-8623-4cca-8723-52b495403461"], "manufacturer_name": ["GADAL Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (53113-516-06)  / 180 mL in 1 BOTTLE", "package_ndc": "53113-516-06", "marketing_start_date": "20250414"}], "brand_name": "DR. SANA PAIN AND FEVER FOR Children", "product_id": "53113-516_d3ebeaac-ec26-4f27-be5d-739918117f2f", "dosage_form": "SYRUP", "product_ndc": "53113-516", "generic_name": "Acetaminophen", "labeler_name": "GADAL Laboratories, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DR. SANA PAIN AND FEVER FOR Children", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}