PainMD Max

Product NDC: 55992-404
11-digit product format: 559920404
Labeler code: 55992
Product ID: 55992-404_d9a1c2da-0ecb-4fce-b846-e06133ccffa8
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin, Histamine Dihydrocholoride
Dosage form: CREAM
Route: TOPICAL
Labeler: OMG Medical Group, LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-07-22
Marketing end: 0000-00-00
Substance: CAPSAICIN; HISTAMINE DIHYDROCHLORIDE
Active strength: 4 mg/mg; mg/mg
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55992-404		I	Inactivated by FDA		2026-10-12
excluded package	package	55992-404	55992-404-11	I	Inactivated by FDA		2026-10-12

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 · 44 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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`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	55992-404-11	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55992-404-11	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55992-404-11	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55992-404-11	2019-11-27	C162847	48780-1	9855e2a2-3978-60a7-e053-dbdaa90a05bd	PainMD Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55992-404-11	PainMD Max	3.75 mg in 1 PACKAGE	CREAM	3.75		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
HISTAMINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3POA0Q644U	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
HISTAMINE	ACTIVE MOIETY	820484N8I3	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
(C10-C30)ALKYL METHACRYLATE ESTER	INACTIVE INGREDIENT	XH2FQZ38D8	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
BOSWELLIA SACRA WHOLE	INACTIVE INGREDIENT	8O600AZL0W	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
CETYL MYRISTOLEATE	INACTIVE INGREDIENT	87P8K33Q5X	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
CUCUMIS SATIVUS WHOLE	INACTIVE INGREDIENT	50560UL2YV	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
ILEX PARAGUARIENSIS WHOLE	INACTIVE INGREDIENT	QJB02841ZY	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES	INACTIVE INGREDIENT	00BT03FSO2	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
TRIETHANOLAMINE BENZOATE	INACTIVE INGREDIENT	M3EN4GC19W	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55992-404	PAINMD MAX (CAPSAICIN, HISTAMINE DIHYDROCHOLORIDE) CREAM [OMG MEDICAL GROUP, LLC]	1	Legacy NDC, 1 package rows	20140722_9d2654e4-ca94-40f2-8480-33c6d79b3a2d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN
3POA0Q644U	HISTAMINE DIHYDROCHLORIDE	56-92-8	HISTAMINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543749	capsaicin 0.375 % / histamine dihydrochloride 0.035 % Topical Cream	PSN	9d2654e4-ca94-40f2-8480-33c6d79b3a2d	1
1543754	PainMD Max 0.375 % / 0035 % Topical Cream	PSN	9d2654e4-ca94-40f2-8480-33c6d79b3a2d	1
1543754	capsaicin 0.375 MG/ML / histamine dihydrochloride 0.35 MG/ML Topical Cream [PainMD Max]	SBD	9d2654e4-ca94-40f2-8480-33c6d79b3a2d	1
1543749	capsaicin 0.375 MG/ML / histamine dihydrochloride 0.35 MG/ML Topical Cream	SCD	9d2654e4-ca94-40f2-8480-33c6d79b3a2d	1
1543754	PainMD Max (capsaicin 0.375 % / histamine dihydrochloride 0.035 % ) Topical Cream	SY	9d2654e4-ca94-40f2-8480-33c6d79b3a2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55992-404-11	55992040411	3.75 mg in 1 PACKAGE	3.75 mg	Historical