Skin Irritant and Healing Support

Product NDC: 44911-0136
Requested package NDC: 44911-0136-1
11-digit product format: 449110136
Labeler code: 44911
Product ID: 44911-0136_97c33b3a-a943-4c13-ae31-fe125d912a5d
Type: HUMAN OTC DRUG
Nonproprietary name: Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (similax regelii)
Dosage form: SPRAY
Route: TOPICAL
Labeler: Energique, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2014-01-07
Marketing end: 2022-09-04
Substance: CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; PLANTAGO MAJOR; SMILAX ORNATA ROOT; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF
Active strength: 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	44911-0136	44911-0136-1	D	Discontinued by firm		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 1 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-05-16	DRUG FACTS:
2022-01-28	DRUG FACTS:
2020-06-29	DRUG FACTS:
2020-01-31	DRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CROTON TIGLIUM SEED	ACTIVE INGREDIENT	0HK2GZK66E	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PLANTAGO MAJOR	ACTIVE INGREDIENT	W2469WNO6U	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SARSAPARILLA	ACTIVE INGREDIENT	2H1576D5WG	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE INGREDIENT	6IO182RP7A	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CROTON TIGLIUM SEED	ACTIVE MOIETY	0HK2GZK66E	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PLANTAGO MAJOR	ACTIVE MOIETY	W2469WNO6U	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SARSAPARILLA	ACTIVE MOIETY	2H1576D5WG	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE MOIETY	6IO182RP7A	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
ACHILLEA MILLEFOLIUM FLOWER	INACTIVE INGREDIENT	YQR8R0SQEA	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
CROTON LECHLERI RESIN	INACTIVE INGREDIENT	GGG6W25C63	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
EGG SHELL MEMBRANE	INACTIVE INGREDIENT	N7QBR4212V	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
HYPERICUM PERFORATUM	INACTIVE INGREDIENT	XK4IUX8MNB	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
LARREA TRIDENTATA TOP	INACTIVE INGREDIENT	PK0TXD049P	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
LAVANDULA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	19AH1RAF4M	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
LECITHIN, SUNFLOWER	INACTIVE INGREDIENT	834K0WOS5G	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
MELISSA OFFICINALIS LEAF	INACTIVE INGREDIENT	50D2ZE9219	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PEG-8 DIMETHICONE	INACTIVE INGREDIENT	GIA7T764OD	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PHYTOLACCA AMERICANA FRUIT	INACTIVE INGREDIENT	WE63661499	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
PHYTOLACCA AMERICANA ROOT	INACTIVE INGREDIENT	11E6VI8VEG	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
POLYETHYLENE GLYCOL 700	INACTIVE INGREDIENT	762678AC5R	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SALIX ALBA BARK	INACTIVE INGREDIENT	205MXS71H7	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SILVER	INACTIVE INGREDIENT	3M4G523W1G	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1
WHEY	INACTIVE INGREDIENT	8617Z5FMF6	SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SIMILAX REGELII)) SPRAY [ENERGIQUE, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
18E7415PXQ	CALENDULA OFFICINALIS FLOWERING TOP		CALENDULA OFFICINALIS FLOWERING TOP
0HK2GZK66E	CROTON TIGLIUM SEED		CROTON TIGLIUM SEED
W2469WNO6U	PLANTAGO MAJOR		PLANTAGO MAJOR
2H1576D5WG	SMILAX ORNATA ROOT		SMILAX ORNATA ROOT
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
6IO182RP7A	TOXICODENDRON PUBESCENS LEAF		TOXICODENDRON PUBESCENS LEAF

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44911-0136-1	44911013601	30 mL in 1 BOTTLE, SPRAY (44911-0136-1)	30 ml	2014-01-07	2022-09-04	No	No	Current