APJ HEMORRHOIDAL

Product NDC: 46084-111
11-digit product format: 460840111
Labeler code: 46084
Product ID: 46084-111_a0c485a4-d719-42e7-8764-459756dfdae3
Type: HUMAN OTC DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM
Dosage form: OINTMENT
Route: TOPICAL
Labeler: A P J Laboratories Limited
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-07-01
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM; MINERAL OIL
Active strength: 3 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	46084-111		I	Inactivated by FDA	2026-10-05
excluded package	package	46084-111	46084-111-10	I	Inactivated by FDA	2026-10-05
excluded package	package	46084-111	46084-111-20	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	46084-111-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-111-10	`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	46084-111-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-111-10	`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	46084-111-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-111-10	`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	46084-111-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-111-10	`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	46084-111-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-111-10	`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	46084-111-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-111-10	`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	46084-111-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-111-10	`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	46084-111-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-111-10	`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	46084-111-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-111-10	`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	46084-111-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-111-10	`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	46084-111-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46084-111-10	`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	46084-111-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46084-111-10	`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	46084-111-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	46084-111-10	`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	46084-111-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	46084-111-10	`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	46084-111-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	46084-111-10	`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	46084-111-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	46084-111-10	`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	46084-111-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	46084-111-10	`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	46084-111-20	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	46084-111-10	`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	46084-111-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	46084-111-10	`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	46084-111-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	46084-111-10	`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
46084-111-10	2019-11-27	C162847	48780-1	9855d018-ed6b-cd31-e053-dbdaa90ab51a	e971a664-c814-4c8a-96ab-7fdaa974335d
46084-111-20	2019-11-27	C162847	48780-1	9855d018-ed6b-cd31-e053-dbdaa90ab51a	e971a664-c814-4c8a-96ab-7fdaa974335d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46084-111-10	APJ HEMORRHOIDAL	28 g in 1 TUBE	OINTMENT	28		1
46084-111-20	APJ HEMORRHOIDAL	57 g in 1 TUBE	OINTMENT	57		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-111	APJ HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM) OINTMENT [A P J LABORATORIES LIMITED]	1	Legacy NDC, 2 package rows	20130701_e971a664-c814-4c8a-96ab-7fdaa974335d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
46084-111-10	46084011110	28 g in 1 TUBE	28 g	Historical
46084-111-20	46084011120	57 g in 1 TUBE	57 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APJ HEMORRHOIDAL - A P J Laboratories Limited	A P J Laboratories Limited	2013-06-01	HUMAN OTC DRUG LABEL	1