Bodewell Eczema Daily Calming

Product NDC: 69423-614
11-digit product format: 694230614
Labeler code: 69423
Product ID: 69423-614_e79f6748-2371-229a-e053-2a95a90ace7c
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal
Dosage form: CREAM
Route: TOPICAL
Labeler: The Procter & Gamble Manufacturing Company
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-02-15
Marketing end: 0000-00-00
Substance: OATMEAL
Active strength: 1 g/100mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69423-614		D	Discontinued by firm	2026-10-16
excluded package	package	69423-614	69423-614-23	D	Discontinued by firm	2026-10-16
excluded package	package	69423-614	69423-614-59	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69423-614-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69423-614-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69423-614-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69423-614-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69423-614-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69423-614-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69423-614-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69423-614-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69423-614-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69423-614-59	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69423-614-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69423-614-59	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69423-614-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69423-614-59	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69423-614-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69423-614-59	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69423-614-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69423-614-59	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69423-614-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69423-614-59	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69423-614-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69423-614-59	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69423-614-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69423-614-59	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	Warnings	Exact identifier application number: M016
GNP Witch Hazel	WITCH HAZEL	Amerisource Bergen	45ac839d-215d-4c5f-8ae5-5e111d170061	2023-12-14	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant	GLYCERIN	L'Oreal USA Products Inc	32eaaaab-41bd-4efe-a71d-92e3a702c1e5	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief	OATMEAL	COSMETIQUE ACTIVE PRODUCTION	e555de17-9b42-4125-a17b-467bc1d179d7	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief	OATMEAL	L'Oreal USA Products Inc	f7b71606-0044-4729-82e8-4514331806a0	2023-12-11	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5	GLYCERIN	Cosmetique Active Production	01c8a0d5-bcd1-4639-be45-530a226401f0	2023-12-11	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	0bc6812a-5c2a-7bb9-e063-6294a90a36e3	2023-12-05	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	34fae56e-367d-4659-af2d-1c9ddaf1639c	2023-12-05	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	0ba98cdf-489e-dc2a-e063-6294a90adb38	2023-12-04	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	0baa8a14-8655-d77c-e063-6294a90ab8aa	2023-12-04	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	86472a3d-7138-4141-8422-ab20c17a46e0	2023-12-04	Warnings	Exact identifier application number: M016
SOOTHE Moisturizing Rescue Cream	OATMEAL	Rodan & Fields	91163267-c2aa-47b3-b290-d1605536d806	2023-12-04	Warnings	Exact identifier application number: M016
Manzatin-E Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	cafd084f-8493-4d6e-b256-2d4b4282f866	2023-12-01	Warnings	Exact identifier application number: M016
Manzatin Diaper Rash Skin Protectant	ZINC OXIDE	Laboratorios Zepol S.A.	5c1618a4-ca08-4814-a556-74e79db618b9	2023-12-01	Warnings	Exact identifier application number: M016

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69423-614-23	69423061423	237 mL in 1 TUBE (69423-614-23)	237 ml	2022-02-15	0000-00-00	No	No	Current
69423-614-59	69423061459	59 mL in 1 TUBE (69423-614-59)	59 ml	2022-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bodewell Eczema Daily Calming Cream	The Procter & Gamble Manufacturing Company	2023-11-15	HUMAN OTC DRUG LABEL	3

Bodewell Eczema Daily Calming

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#