PRO-CHLO

Product NDC: 66594-321
11-digit product format: 665940321
Labeler code: 66594
Product ID: 66594-321_43da4965-15ef-4716-95a6-ea67a636ae43
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Pyrilamine Maleate
Dosage form: LIQUID
Route: ORAL
Labeler: Pro-Pharma, LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-12-12
Marketing end: 0000-00-00
Substance: CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength: 13 mg/5mL; mg/5mL; mg/5mL
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	66594-321		I	Inactivated by FDA	2026-10-05
excluded package	package	66594-321	66594-321-01	I	Inactivated by FDA	2026-10-05
excluded package	package	66594-321	66594-321-16	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	66594-321-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66594-321-01	`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	66594-321-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66594-321-01	`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	66594-321-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66594-321-01	`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	66594-321-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66594-321-01	`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	66594-321-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66594-321-01	`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	66594-321-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66594-321-01	`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	66594-321-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66594-321-01	`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	66594-321-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66594-321-01	`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	66594-321-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66594-321-01	`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	66594-321-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66594-321-01	`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	66594-321-16	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66594-321-01	`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	66594-321-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66594-321-01	`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	66594-321-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66594-321-01	`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	66594-321-16	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66594-321-01	`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	66594-321-16	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66594-321-01	`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	66594-321-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66594-321-01	`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	66594-321-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66594-321-01	`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	66594-321-16	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66594-321-01	`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	66594-321-16	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66594-321-01	`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	66594-321-16	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66594-321-01	`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
66594-321-01	2019-11-13	C162847	48780-1	97449f38-ca22-f6ea-e053-dbdaa90aa703	PRO-CHLO LIQUID
66594-321-16	2019-11-13	C162847	48780-1	97449f38-ca22-f6ea-e053-dbdaa90aa703	PRO-CHLO LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66594-321-01	PRO-CHLO	30 mL in 1 BOTTLE	LIQUID	30		1
66594-321-16	PRO-CHLO	473 mL in 1 BOTTLE	LIQUID	473		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66594-321-16	ML - Milliliter	66594-321	53d029ae-2f64-49df-892e-6546506be45b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlophedianol Hydrochloride	ACTIVE INGREDIENT	69QQ58998Y	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Pyrilamine Maleate	ACTIVE INGREDIENT	R35D29L3ZA	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Chlophedianol	ACTIVE MOIETY	42C50P12AP	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Pyrilamine	ACTIVE MOIETY	HPE317O9TL	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66594-321	PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]	1	Legacy NDC, 2 package rows	20120214_c767a626-a3ce-490c-a511-00749784acab.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1192685	chlophedianol HCl 12.5 MG / phenylephrine HCl 5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral Solution	PSN	c767a626-a3ce-490c-a511-00749784acab	1
1192685	chlophedianol hydrochloride 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML / pyrilamine maleate 2.5 MG/ML Oral Solution	SCD	c767a626-a3ce-490c-a511-00749784acab	1
1192685	chlophedianol hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral Solution	SY	c767a626-a3ce-490c-a511-00749784acab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66594-321-01	66594032101	30 mL in 1 BOTTLE	30 ml	Historical
66594-321-16	66594032116	473 mL in 1 BOTTLE	473 ml	Historical