HemAway

Product NDC: 54473-180
11-digit product format: 544730180
Labeler code: 54473
Product ID: 54473-180_7db048a3-6556-41d8-a5fe-b75e462d266e
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocane and Phenylephrine HCL
Dosage form: CREAM
Route: TOPICAL
Labeler: Melaleuca, Inc.
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-12-13
Marketing end: 0000-00-00
Substance: LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 50 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	54473-180		I	Inactivated by FDA		2026-10-05
excluded package	package	54473-180	54473-180-01	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 1 · 42 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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`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	54473-180-01	`9bebd1f3094a…`	`5416666fcb17…`

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
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-180-01	2020-01-31	C162847	48780-1	9d75b9d1-0ab9-f424-e053-dadaa90a57ce	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-180-01	HemAway	1 in 1 BOX	CREAM	1		1
54473-180-01	HemAway	28 g in 1 TUBE	CREAM	28		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
GRAPE	INACTIVE INGREDIENT	6X543N684K	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
HYDROGENATED SOYBEAN LECITHIN	INACTIVE INGREDIENT	H1109Z9J4N	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-180	HEMAWAY (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [MELALEUCA, INC.]	1	Legacy NDC, 2 package rows	20121007_9e1f7343-17c7-45f8-963d-ba1a21d4b0f1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1314141	HemAway 5 % / 0.25 % Rectal Cream	PSN	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1
1314136	lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream	PSN	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1
1314141	lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [Hemaway]	SBD	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1
1314136	lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream	SCD	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1
1314141	HemAway (lidocaine 5 % / phenylephrine hydrochloride 0.25 % ) Rectal Cream	SY	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1
1314136	lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream	SY	9e1f7343-17c7-45f8-963d-ba1a21d4b0f1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54473-180-01	54473018001	1 in 1 BOX	Historical