Caldesene Baby

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: Caldesene Baby
Generic name: STARCH, CORN AND ZINC OXIDE
Manufacturer: Insight Pharmaceuticals LLC
Product type: HUMAN OTC DRUG
SPL set ID: 9f12dee2-7afa-45e9-a729-0fd42bb77715
SPL ID: 8fd854c9-b6c2-4991-a592-4d102ca0ecf9
Version: 6
Effective date: 2026-04-22
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/8ec9b1418c25a8bb472a36e6bc0b2cbabb210d48d5dd734197e022d21529ed58/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:16:51

Harmonized routes table
Harmonized routes
TOPICAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Caldesene Baby	openfda.brand_name
generic name		STARCH, CORN AND ZINC OXIDE	openfda.generic_name
manufacturer name		Insight Pharmaceuticals LLC	openfda.manufacturer_name
ndc	package	63736-305-05	openfda.package_ndc
ndc	product	63736-305	openfda.product_ndc
ndc11	package	63736030505	derived:openfda.package_ndc
rxcui		1039057	openfda.rxcui
rxcui		1039054	openfda.rxcui
spl id		8fd854c9-b6c2-4991-a592-4d102ca0ecf9	id
spl set id		9f12dee2-7afa-45e9-a729-0fd42bb77715	set_id
unii		SOI2LOH54Z	openfda.unii
unii		O8232NY3SJ	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 For external use only . Do not use on broken skin. When using this product do not get into eyes keep away from child's face and mouth to avoid breathing it Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.