Home FDA labels 308ccf50-c319-2cd0-e063-6394a90aa99e Baby Nighttime Oral Pain Relief openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Baby Nighttime Oral Pain Relief
Generic name ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE
Manufacturer Hyland' Inc.
Product type HUMAN OTC DRUG
SPL set ID 58ef86b7-5b38-1591-e053-2991aa0aa53e
SPL ID 308ccf50-c319-2cd0-e063-6394a90aa99e
Version 13
Effective date 2025-03-17
Source export date 2026-09-28
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:48:04 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 18 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name Baby Nighttime Oral Pain Relief openfda.brand_name generic name ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE openfda.generic_name manufacturer name Hyland' Inc. openfda.manufacturer_name ndc package 54973-3324-1 openfda.package_ndc ndc package 54973-3324-4 openfda.package_ndc ndc product 54973-3324 openfda.product_ndc ndc11 package 54973332404 derived:openfda.package_ndc ndc11 package 54973332401 derived:openfda.package_ndc spl id 308ccf50-c319-2cd0-e063-6394a90aa99e id spl set id 58ef86b7-5b38-1591-e053-2991aa0aa53e set_id unii 3SW678MX72 openfda.unii unii O80TY208ZW openfda.unii unii 91D9GV0Z28 openfda.unii unii HF539G9L3Q openfda.unii unii ETJ7Z6XBU4 openfda.unii unii 2E32821G6I openfda.unii unii 91GQH8I5F7 openfda.unii unii G0R4UBI2ZZ openfda.unii
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings Warnings Stop use and ask a doctor if ■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens. Keep out of reach of children
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.