NDC 42957-002-01 - BabySpa Calming Relief Eczema

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 42957-002
Requested NDC: 42957-002-01
Package NDCs from labels: 42957-002-01, 42957-002-02, 42957-002-03
Manufacturer: Expro3, LLC | EL Erman Manufacturing, Ltd.
Effective date: 2013-03-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
BabySpa Calming Relief Eczema - Expro3, LLC \| EL Erman Manufacturing, Ltd.	Expro3, LLC \| EL Erman Manufacturing, Ltd.	2013-03-07	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42957-002-02	2019-11-27	C162847	48780-1	9855d018-da21-cd31-e053-dbdaa90ab51a	4999358e-e799-4267-9a0f-336a948d9d87
42957-002-03	2019-11-27	C162847	48780-1	9855d018-da21-cd31-e053-dbdaa90ab51a	4999358e-e799-4267-9a0f-336a948d9d87

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42957-002-01	BabySpa Calming Relief Eczema	125 g in 1 TUBE	CREAM	125	1
42957-002-02	BabySpa Calming Relief Eczema	1 in 1 BOX	CREAM	1	1
42957-002-03	BabySpa Calming Relief Eczema	4 g in 1 POUCH	CREAM	4	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42957-002	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1	Legacy NDC, 3 package rows	20130325_4999358e-e799-4267-9a0f-336a948d9d87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
OATMEAL	ACTIVE MOIETY	8PI54V663Y	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]	1

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 38 of 40 · 781 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier unii: PDC6A3C0OX
GUNA-LYMPHO	APIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - MAGNESIUM PHOSPHATE - MALIC ACID - MYOSOTIS ARVENSIS - PHYTOLACCA AMERICANA ROOT - SARSAPARILLA - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - TARAXACUM OFFICINALE -	Guna spa	ecd11761-9b9c-4d42-9e2b-f03ba4fed8ae	2022-11-14	Warnings	Exact identifier unii: P0M7O4Y7YD
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
REFRESH OPTIVE	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	7f8d88af-fd3b-4138-af61-f24c59ccebd7	2022-09-23	Warnings	Exact identifier unii: PDC6A3C0OX
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier unii: PDC6A3C0OX
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier unii: PDC6A3C0OX
Glycerinum	GLYCERINUM	Hahnemann Laboratories, INC.	e34f8796-85b5-2946-e053-2995a90a251e	2022-07-08		Exact identifier unii: PDC6A3C0OX
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: PDC6A3C0OX
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Miracle FootCream Lavender	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db520c80-2a2a-5eb1-e053-2995a90a5bb4	2022-03-28	Warnings	Exact identifier unii: PDC6A3C0OX unii: ZY81Z83H0X
Miracle FootCream Lemon	UREA, GLYCERIN, ALOE, DISODIUM EDTA	Aloe Vera Korea Co.,Ltd.	db525c63-29fd-2033-e053-2995a90a56b9	2022-03-28	Warnings	Exact identifier unii: PDC6A3C0OX unii: ZY81Z83H0X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier unii: 8PI54V663Y
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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