Signature Care Hemorrhoidal

Product NDC: 21130-789
11-digit product format: 211300789
Labeler code: 21130
Product ID: 21130-789_4a197084-aa10-02ef-e063-6394a90a1e46
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral oil, Petrolatum, and Phenylephrine HCI
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Better Living Brands, LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-20
Substance: PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL
Active strength: 749; 2.5; 140 mg/g; mg/g; mg/g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21130-789-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21130-789-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21130-789-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21130-789-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21130-789-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21130-789-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21130-789-14	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21130-789-14	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21130-789-14	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Signature Care Hemorrhoidal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	749 mg/g
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
MINERAL OIL	140 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
T5L8T28FGP	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
3c8b43f3-6e1e-499e-ba71-ffdf836f6743	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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
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
21130-789-14	2025-01-30	C162847	48780-1	2cef2736-b62b-d83d-e063-dadaa90ab31f	Signature Care Hemorrhoidal Ointment 1 oz (with applicator) 78982 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-789-14	Signature Care Hemorrhoidal	1 in 1 CARTON	OINTMENT	1		7
21130-789-14	Signature Care Hemorrhoidal	28 g in 1 TUBE	OINTMENT	28		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-789	SIGNATURE CARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI) OINTMENT [BETTER LIVING BRANDS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20221217_3c8b43f3-6e1e-499e-ba71-ffdf836f6743.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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DRMITSUI MEDICAL HAEMORRHOID	PHENYLEPHRINE HCI WITCH HAZEL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	51720221-893b-cade-e063-6394a90adaec	2026-05-10	Warnings	Exact identifier application number: M015
Glycerin	GLYCERIN SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	374a2ca3-ee04-09a7-e063-6394a90ab760	2026-05-05	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	32ab24b4-dcec-4a09-e054-00144ff88e88	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	c2c0cb17-401a-4ba2-aa04-64c9b43cd21b	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	e840fba4-86ff-9da0-e053-2995a90a221a	2026-04-30	Warnings	Exact identifier application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPES	WITCH HAZEL	Family Dollar Stores, Inc	3f6f68c0-787a-48eb-b042-d4df90ea7e03	2026-04-17	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a6ed1987-37ad-4bfd-8cea-f03426953f5a	2026-04-16	Warnings	Exact identifier application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTS	LIDOCAINE, PHENYLEPHRINE	Guangdong Quadrant Ecological Technology Co., Ltd.	4f1634d5-7667-b354-e063-6394a90a34e7	2026-04-10	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Lidocaine	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	4f1ef866-c4af-989b-e063-6294a90a148e	2026-04-10	Warnings	Exact identifier application number: M015
Thera Plus Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Fourstar Group USA, Inc.	5d63bf97-29d2-4c71-97c3-85f425e86207	2026-04-07	Warnings	Exact identifier application number: M015
Walgreens Pain Relief with Lidocaine	LIDOCAINE, PHENYLEPHRINE HCL	Walgreens Co	3ce78f2f-0264-f406-e063-6294a90a7e03	2026-04-01	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	5256a84a-8dac-8fd4-e063-6294a90a616c	2026-04-01	Warnings	Exact identifier application number: M015
Hemorrhoidal	LIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUM	Walgreens Co	3d213ba8-3cbe-11c4-e063-6394a90ae016	2026-03-30	Warnings	Exact identifier application number: M015
Critic Aid Skin	ZINC OXIDE	Coloplast Corp	caaac1f0-437d-4185-8670-9f11b9cefe63	2026-03-30	Warnings	Exact identifier application number: M015
CVS Topical Analgesic Hemorrhoidal	DIBUCAINE	CVS PHARMACY,INC	b9e20531-3444-4955-b1d3-bb112340d230	2026-03-27	Warnings	Exact identifier application number: M015
Walgreens Moisture Barrier	WALGREENS MOISTURE BARRIER	Walgreens	44fc098c-1f5f-bf82-e063-6294a90a1405	2026-03-25	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	472fe0d1-31a1-fded-e063-6394a90a4a66	2026-03-25	Warnings	Exact identifier application number: M015
Hemorrhoid Relief Cream	LIDOCAINE 5% ANORECTAL	ALAINA HEALTHCARE PRIVATE LIMITED	53b2c3b0-d729-44d6-bc64-a9e1c9351877	2026-03-23	Warnings	Exact identifier application number: M015
LIDOCAINE	LIDOCAINE	YYBA Corp	4db609cc-f329-62a4-e063-6394a90aefc1	2026-03-23	Warnings	Exact identifier application number: M015
Topical Hemorrhoid Relief Gel	MENTHOL, UNSPECIFIED FORM	Yantai Aien Biotechnology Co., Ltd.	4d6e6667-ab1c-de7c-e063-6294a90a0b9b	2026-03-20	Warnings	Exact identifier application number: M015

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

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	3c8b43f3-6e1e-499e-ba71-ffdf836f6743	7
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	3c8b43f3-6e1e-499e-ba71-ffdf836f6743	7
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	3c8b43f3-6e1e-499e-ba71-ffdf836f6743	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-789-14	21130078914	1 TUBE in 1 CARTON (21130-789-14) / 28 g in 1 TUBE	1 tube	2016-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Care Hemorrhoidal Ointment 1 oz (with applicator) 78982 ZDP	Better Living Brands, LLC	2026-02-05	HUMAN OTC DRUG LABEL	7