CalmaFX

Product NDC: 75904-3246
11-digit product format: 759043246
Labeler code: 75904
Product ID: 75904-3246_5ba9ed70-fdbd-435c-ae6f-b6f14e573bca
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CALAMINE, ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: First Choice Medical Supply
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-02-28
Marketing end: 0000-00-00
Substance: MENTHOL; FERRIC OXIDE RED; ZINC OXIDE
Active strength: 5 mg/g; mg/g; mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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	75904-3246		I	Inactivated by FDA	2026-10-05
excluded package	package	75904-3246	75904-3246-0	I	Inactivated by FDA	2026-10-05
excluded package	package	75904-3246	75904-3246-3	I	Inactivated by FDA	2026-10-05

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 2 · 66 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	75904-3246-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75904-3246-0	`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	75904-3246-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75904-3246-0	`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	75904-3246-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75904-3246-0	`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	75904-3246-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75904-3246-0	`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	75904-3246-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75904-3246-0	`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	75904-3246-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75904-3246-0	`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	75904-3246-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75904-3246-0	`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	75904-3246-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75904-3246-0	`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	75904-3246-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75904-3246-0	`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	75904-3246-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	75904-3246-0	`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	75904-3246-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	75904-3246-0	`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	75904-3246-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75904-3246-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75904-3246-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75904-3246-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75904-3246-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75904-3246-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75904-3246-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75904-3246-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75904-3246-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75904-3246-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75904-3246-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75904-3246-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75904-3246-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75904-3246-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75904-3246-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	75904-3246-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75904-3246-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	75904-3246-0	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75904-3246-0	2019-11-27	C162847	48780-1	9855d018-d4a2-cd31-e053-dbdaa90ab51a	CalmaFX Moisture Barrier Ointment Drug Facts
75904-3246-3	2019-11-27	C162847	48780-1	9855d018-d4a2-cd31-e053-dbdaa90ab51a	CalmaFX Moisture Barrier Ointment Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75904-3246-0	CalmaFXMoisture Barrier	113 g in 1 TUBE	OINTMENT	113		4
75904-3246-3	CalmaFXMoisture Barrier	5 g in 1 POUCH	OINTMENT	5		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75904-3246	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4	Legacy NDC, 2 package rows	20130325_7b52374e-1119-4145-b87b-96b7212fdc3e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373249	calamine 2 % / menthol 0.45 % / zinc oxide 18 % Topical Ointment	PSN	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373254	CalmaFX 2 % / 0.45 % / 18 % Topical Ointment	PSN	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373254	calamine 0.02 MG/MG / menthol 0.0045 MG/MG / zinc oxide 0.18 MG/MG Topical Ointment [Calmafx]	SBD	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373249	calamine 0.02 MG/MG / menthol 0.0045 MG/MG / zinc oxide 0.18 MG/MG Topical Ointment	SCD	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373249	Calamine 0.02 MG/MG / Menthol 0.0045 MG/MG / ZNO 0.18 MG/MG Topical Ointment	SY	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373254	Calamine 0.02 MG/MG / Menthol 0.0045 MG/MG / ZNO 0.18 MG/MG Topical Ointment [Calmafx]	SY	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373249	calamine 2 % / menthol 0.45 % / zinc oxide 18 % Topical Ointment	SY	7b52374e-1119-4145-b87b-96b7212fdc3e	4
1373254	CalmaFX (calamine 2 % / menthol 0.45 % / zinc oxide 18 % ) Topical Ointment	SY	7b52374e-1119-4145-b87b-96b7212fdc3e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
75904-3246-0	75904324600	113 g in 1 TUBE	113 g	Historical
75904-3246-3	75904324603	5 g in 1 POUCH	5 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CalmaFX Moisture Barrier Ointment Drug Facts	First Choice Medical Supply \| Summit Industries, Inc.	2013-03-22	HUMAN OTC DRUG LABEL	4