HemorrhoidalOintment

Product NDC: 69396-020
11-digit product format: 693960020
Labeler code: 69396
Product ID: 69396-020_37247f04-c552-7e53-e063-6394a90a162e
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil, Petrolatum, Phenylephrine HCI
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Trifecta Pharmaceuticals USA LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-05-04
Substance: MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 14; 74.9; .25 g/100g; g/100g; g/100g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	69396-020		I	Inactivated by FDA		2026-10-15
excluded package	package	69396-020	69396-020-05	I	Inactivated by FDA		2026-10-15

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 · 30 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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`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	69396-020-05	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: HemorrhoidalOintment
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	14 g/100g
PETROLATUM	74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1372298	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4eb3c9ac-268a-5246-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
69396-020-05	2023-01-30	C162847	48780-1	f386c649-bd82-0266-e053-dadaa90a7c1a	Hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69396-020-01	HemorrhoidalOintment	1 in 1 BOX	OINTMENT	1	10
69396-020-01	HemorrhoidalOintment	28.4 g in 1 TUBE	OINTMENT	28.4	10
69396-020-02	HemorrhoidalOintment	56 g in 1 TUBE	OINTMENT	56	10
69396-020-02	HemorrhoidalOintment	1 in 1 BOX	OINTMENT	1	10
69396-020-33	HemorrhoidalOintment	56 g in 1 TUBE	OINTMENT	56	10
69396-020-33	HemorrhoidalOintment	3 in 1 BOX	OINTMENT	3	10
69396-020-44	HemorrhoidalOintment	56 g in 1 TUBE	OINTMENT	56	10
69396-020-44	HemorrhoidalOintment	4 in 1 BOX	OINTMENT	4	10
69396-020-05	HemorrhoidalOintment	1 in 1 BOX	OINTMENT	1	2
69396-020-05	HemorrhoidalOintment	15 g in 1 TUBE	OINTMENT	15	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69396-020-02	GM - Gram	69396-020	698cc26a-2995-43a0-9068-d32735766a2d	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-020	HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]	9	Current NDC, Legacy NDC, 8 package rows	20250305_4eb3c9ac-268a-5246-e054-00144ff88e88.zip
69396-020	HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]	2	Current NDC, Legacy NDC, 2 package rows	20171120_44cfb486-a5fd-10ee-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 15 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Anal Glide Extra	BENZOCAINE	PRODUCT MAX GROUP INC	282ac8d3-2caf-42de-b347-450e9c7a9e50	2025-04-03	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	984c4bee-0d44-4e0f-a057-0d54400c4cac	2025-04-02	Warnings	Exact identifier application number: M015
hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Bionpharma Inc.	1790da99-2a22-e2a2-e063-6394a90ac36f	2025-03-31	Warnings	Exact identifier application number: M015
HemAway	LIDOCAINE	Melaleuca, Inc.	cf842adf-fcd7-2c8c-e053-2995a90adea6	2025-03-27	Warnings	Exact identifier application number: M015
Numb and Number Anorectal Cream	LIDOCAINE	Dermtech Labs, Inc	31420635-5021-173d-e063-6294a90a407a	2025-03-26	Warnings	Exact identifier application number: M015
Leader Maximum Strength Hemorrhoidal Relief	LIDOCAINE	Cardinal Health,Inc.	65c780b0-7f47-4ae9-a847-c22deaaa2888	2025-03-21	Warnings	Exact identifier application number: M015
Curist Hemorrhoid Fissure Relief	LIDOCAINE	Little Pharma, Inc	2fb02b00-acdb-5184-e063-6294a90ae1c8	2025-03-06	Warnings	Exact identifier application number: M015
Thera Plus Hemorrhoidal	GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	FOURSTAR GROUP USA, INC.	87143a7a-7b2d-4b67-afda-2355697e7300	2025-03-04	Warnings	Exact identifier application number: M015
Numbskin Maximum Strength Pain Reliever	LIDOCAINE	Shinpharma Inc	2f288bde-99fd-42f8-e063-6394a90a0f05	2025-02-27	Warnings	Exact identifier application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPES	WITCH HAZEL	Haleon US Holdings LLC	1953ec64-20ce-488b-8f14-44e15cc9e720	2025-02-21	Warnings	Exact identifier application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief Cream	MENTHOL, METHYL SALICYLATE	L'BRI HEALTH AND BEAUTY INC	62e18a37-c0db-4b1e-a6a1-35684cc00e08	2025-01-28	Warnings	Exact identifier application number: M015
Hemorrhoidal	PAIN RELIEF	NeilMed Pharmaceuticals Inc.	038a2cf5-1b72-227b-e063-6394a90a84ad	2025-01-24	Warnings	Exact identifier application number: M015
lidocaine	LIDOCAINE	Nivagen Pharmaceuticals, Inc.	32964ec3-1880-477b-9f71-2222c39106aa	2025-01-23	Warnings	Exact identifier application number: M015
Hemorrhoidal cocoa butter	HEMORRHOIDAL	NeilMed Pharmaceuticals Inc.	03b159b0-b960-b38d-e063-6394a90a9462	2025-01-17	Warnings	Exact identifier application number: M015
Gentle Laxative Bisacodyl	GENTLE LAXATIVE BISACODYL	NeilMed Pharmaceuticals Inc	03b3733a-4d78-149f-e063-6294a90a6518	2025-01-17	Warnings	Exact identifier application number: M015
Glycerin Laxative	GLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEF	NeilMed Pharmaceuticals Inc.	03b4be69-6488-76be-e063-6394a90a7edf	2025-01-17	Warnings	Exact identifier application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent	WITCH HAZEL	Walgreens Company	209a111b-d169-cb5d-e063-6394a90a33ca	2025-01-15	Warnings	Exact identifier application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel	WITCH HAZEL	Walgreens Company	1e2dcec1-a1fe-71d2-e063-6394a90a9908	2025-01-15	Warnings	Exact identifier application number: M015
AER Pre-moistened Witch Hazel Pad	WITCH HAZEL	Birchwood Laboratories LLC	1cca622f-0a6b-4f35-9355-34c249ee705e	2025-01-14	Warnings	Exact identifier application number: M015
B-SURE Traveler Towelette	B-SURE TRAVELER	Birchwood Laboratories LLC	e1a5da94-6a1a-497b-a737-1c1541bf0404	2025-01-14	Warnings	Exact identifier application number: M015

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	4eb3c9ac-268a-5246-e054-00144ff88e88	10
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	4eb3c9ac-268a-5246-e054-00144ff88e88	10
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	4eb3c9ac-268a-5246-e054-00144ff88e88	10
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	44cfb486-a5fd-10ee-e054-00144ff8d46c	2
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	44cfb486-a5fd-10ee-e054-00144ff8d46c	2
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	44cfb486-a5fd-10ee-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-020-01	69396002001	1 TUBE in 1 BOX (69396-020-01) / 28.4 g in 1 TUBE	1 tube	2020-09-14	0000-00-00	No	No	Current
69396-020-02	69396002002	1 TUBE in 1 BOX (69396-020-02) / 56 g in 1 TUBE	1 tube	2017-05-04	0000-00-00	No	No	Current
69396-020-05	69396002005	1 TUBE in 1 BOX (69396-020-05) > 15 g in 1 TUBE	1 tube	2016-12-29	0000-00-00	No	No	Current
69396-020-33	69396002033	3 TUBE in 1 BOX (69396-020-33) / 56 g in 1 TUBE	3 tube	2024-03-12		No	No	Current
69396-020-44	69396002044	4 TUBE in 1 BOX (69396-020-44) / 56 g in 1 TUBE	4 tube	2024-03-12		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemorrhoidal Ointment	Trifecta Pharmaceuticals USA LLC	2025-06-09	HUMAN OTC DRUG LABEL	10
Hemorrhoidal Ointment	Trifecta Pharmaceuticals Usa Llc	2017-11-20	HUMAN OTC DRUG LABEL	2