PREPARATION H

Product NDC: 0573-2883
11-digit product format: 005732883
Labeler code: 0573
Product ID: 0573-2883_12ad4740-7bea-f822-e063-6394a90a0e38
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Haleon US Holdings LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-05
Substance: COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2211; 6.25 mg/1; mg/1
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0573-2883	0573-2883-10	D	Discontinued by firm	2026-10-12
excluded package	package	0573-2883	0573-2883-11	D	Discontinued by firm	2026-10-12
excluded package	package	0573-2883	0573-2883-20	D	Discontinued by firm	2026-10-12
excluded package	package	0573-2883	0573-2883-30	D	Discontinued by firm	2026-10-12
excluded package	package	0573-2883	0573-2883-55	D	Discontinued by firm	2026-10-12

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 · 68 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 package	package	0573-2883-20	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-2883-55	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-2883-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-2883-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-2883-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2883-20	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2883-55	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2883-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2883-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2883-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2883-20	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2883-55	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2883-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2883-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2883-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2883-20	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2883-55	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2883-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2883-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2883-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2883-20	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2883-55	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2883-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2883-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2883-11	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2883-20	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2883-55	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2883-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2883-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2883-11	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2883-20	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2883-55	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2883-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2883-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2883-11	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2883-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2883-55	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2883-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2883-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2883-11	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2883-20	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2883-55	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2883-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2883-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2883-11	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2883-20	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2883-55	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2883-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2883-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2883-11	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2883-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2883-11	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2883-20	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2883-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2883-55	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2883-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2883-11	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2883-20	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`

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: PREPARATION H
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COCOA BUTTER	2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE	6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
512OYT1CRR	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
1438497	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
a23ded81-78ba-c199-a8f0-aaf360b216ff	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, Related label table
NDC	Effective	Related label
0573-2883-10	2023-05-17	Drug Facts
0573-2883-11	2023-05-17	Drug Facts
0573-2883-20	2023-05-17	Drug Facts
0573-2883-30	2023-05-17	Drug Facts
0573-2883-55	2023-05-17	Drug Facts
0573-2883-10	2022-01-28	Drug Facts
0573-2883-11	2022-01-28	Drug Facts
0573-2883-20	2022-01-28	Drug Facts
0573-2883-30	2022-01-28	Drug Facts
0573-2883-55	2022-01-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-2883-10	PREPARATION H	12 in 1 CARTON	SUPPOSITORY	12	18
0573-2883-10	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1	18
0573-2883-11	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1	18
0573-2883-11	PREPARATION H	12 in 1 CARTON	SUPPOSITORY	12	18
0573-2883-20	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1	18
0573-2883-20	PREPARATION H	24 in 1 CARTON	SUPPOSITORY	24	18
0573-2883-30	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1	18
0573-2883-30	PREPARATION H	48 in 1 CARTON	SUPPOSITORY	48	18
0573-2883-55	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1	18
0573-2883-55	PREPARATION H	56 in 1 CARTON	SUPPOSITORY	56	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2883-10	EA - Each	0573-2883	373d7bb4-6a34-445e-8ed9-414e765db74e	1	2012-07-24
0573-2883-11	EA - Each	0573-2883	e14cdc2f-07ae-41e3-badf-5eacdb4ff969	1	2017-03-06
0573-2883-20	EA - Each	0573-2883	9a9b01fd-67bf-4599-a5c7-29fbfa7d9a60	1	2012-07-24
0573-2883-30	EA - Each	0573-2883	ccc9e478-d835-4450-bc2b-2399ccf1eff0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2883	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC]	18	Current NDC, Legacy NDC, 10 package rows	20240303_a23ded81-78ba-c199-a8f0-aaf360b216ff.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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots	LIDOCAINE	CVS PHARMACY, INC	caef51a8-76e9-42b3-a160-c54f62b47de1	2026-01-05	Warnings	Exact identifier application number: M015
CVS Maximum OTC Strength Hemorrhoidal with Aloe	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY,INC	b55c63fb-5dfa-4567-8192-58f403868837	2026-01-02	Warnings	Exact identifier application number: M015
HemRid Anorectal Cream	LIDOCAINE	KKA & Associates LLC	dbeb4325-3e85-1147-e053-2995a90a2160	2025-12-31	Warnings	Exact identifier application number: M015
ElixirCurozole	CLOTRIMAZOLE	ELIXIR HEALTHCARE USA, LLC.	0c468a9e-d092-4704-b742-92ecd9918209	2025-12-26	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	5162baee-0d63-494e-8046-459437b85348	2025-12-25	Warnings	Exact identifier application number: M015
HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Safeway	3e6728b6-26e3-4287-8ba6-e27f305cd93b	2025-12-20	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	40fde50a-3cc0-4286-9b33-8f3912254c33	2025-12-18	Warnings	Exact identifier application number: M015
ElixirLidoFast Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	ELIXIR HEALTHCARE USA, LLC.	45de9dfa-6c89-1eae-e063-6294a90a4dac	2025-12-13	Warnings	Exact identifier application number: M015
topcare hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Topco Associates LLC	81a3546b-5099-4b9a-b774-b3e79316b267	2025-12-13	Warnings	Exact identifier application number: M015
Kroger Hemorrhoid	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Kroger Company	45b2dd86-7fb0-07bf-e063-6394a90a1884	2025-12-11	Warnings	Exact identifier application number: M015
LMX5	LIDOCAINE	Ferndale Laboratories, Inc.	34f8ed6b-4a52-4a99-9c1b-254196dc29b0	2025-12-10	Warnings	Exact identifier application number: M015
PURA	WITCH HAZEL	Mypura.com Limited	1523f52f-6a5b-a12d-e063-6294a90a4496	2025-12-05	Warnings	Exact identifier application number: M015
Menthol and Zinc Oxide	MENTHOL AND ZINC OXIDE	Marlex Pharmaceuticals, Inc.	c24e2dab-cab4-38f4-e053-2995a90aabae	2025-12-04	Warnings	Exact identifier application number: M015
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	7913bd41-a606-4ca6-b69f-2717c2f54b07	2025-12-01	Warnings	Exact identifier application number: M015
Dr Butlers Hemorrhoid and Fissure PF	LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25	Beyond Health P.A.	f526199e-5c9e-7a3c-e053-2a95a90aa98e	2025-11-26	Warnings	Exact identifier application number: M015
Meicated Wipe	WITCH HAZEL	Diamond Wipes International, Inc	4458c80c-d013-55ba-e063-6394a90a6b39	2025-11-24	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	804d7b1f-1be8-50c9-e053-2a91aa0a35d0	2025-11-18	Warnings	Exact identifier application number: M015
Launch Medical	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	293ef514-44c1-43ac-9a81-c30e34ad39e5	2025-11-12	Warnings	Exact identifier application number: M015
FARGELIN HEMORRHOIDAL	CALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDE	MADISON ONE ACME INC	6844ad63-512d-496a-9458-011894185b0d	2025-11-10	Warnings	Exact identifier application number: M015
Hazel Perineal Healing Foam	WITCH HAZEL	Jiangsu Senwo Medical Technology Co., Ltd.	314b75cb-affe-a248-e063-6294a90a47b7	2025-11-07	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	a23ded81-78ba-c199-a8f0-aaf360b216ff	18
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	a23ded81-78ba-c199-a8f0-aaf360b216ff	18
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	a23ded81-78ba-c199-a8f0-aaf360b216ff	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2883-10	00573288310	12 BLISTER PACK in 1 CARTON (0573-2883-10) > 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2004-01-05	0000-00-00	No	No	Current
0573-2883-11	00573288311	12 BLISTER PACK in 1 CARTON (0573-2883-11) > 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2004-01-05	0000-00-00	No	No	Current
0573-2883-20	00573288320	24 BLISTER PACK in 1 CARTON (0573-2883-20) > 1 SUPPOSITORY in 1 BLISTER PACK	24 blister pack	2004-01-05	0000-00-00	No	No	Current
0573-2883-30	00573288330	48 BLISTER PACK in 1 CARTON (0573-2883-30) > 1 SUPPOSITORY in 1 BLISTER PACK	48 blister pack	2004-01-05	0000-00-00	No	No	Current
0573-2883-55	00573288355	56 BLISTER PACK in 1 CARTON (0573-2883-55) > 1 SUPPOSITORY in 1 BLISTER PACK	56 blister pack	2004-01-05	0000-00-00	No	No	Current