Chlo Hist

Product NDC: 12830-864
11-digit product format: 128300864
Labeler code: 12830
Product ID: 12830-864_413d8eeb-e320-427b-e063-6394a90a9fe4
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol Hydrochloride, Dexbrompheniramine Maleate
Dosage form: LIQUID
Route: ORAL
Labeler: R. A. McNeil Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-15
Substance: CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE
Active strength: 12.5; 1 mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	12830-864-04
excluded package	package	12830-864-20
excluded package	package	12830-864-16

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: Chlo Hist
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg/5mL
DEXBROMPHENIRAMINE MALEATE	1 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69QQ58998Y	Internal UNII lookup
BPA9UT29BS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1551286	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
d046f4ba-5753-4ed5-a924-0b66fd116781	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
12830-864-04	2022-12-22	Chlo Hist Oral Solution
12830-864-04	2022-12-22	Chlo Hist Oral Solution
12830-864-16	2022-12-22	Chlo Hist Oral Solution
12830-864-16	2022-12-22	Chlo Hist Oral Solution
12830-864-20	2022-12-22	Chlo Hist Oral Solution
12830-864-20	2022-12-22	Chlo Hist Oral Solution
12830-864-04	2022-07-29	Chlo Hist Oral Solution
12830-864-04	2022-07-29	Chlo Hist Oral Solution
12830-864-16	2022-07-29	Chlo Hist Oral Solution
12830-864-16	2022-07-29	Chlo Hist Oral Solution
12830-864-20	2022-07-29	Chlo Hist Oral Solution
12830-864-20	2022-07-29	Chlo Hist Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12830-864-04	Chlo Hist	120 mL in 1 BOTTLE	LIQUID	120	13
12830-864-16	Chlo Hist	473 mL in 1 BOTTLE	LIQUID	473	13
12830-864-20	Chlo Hist	20 mL in 1 BOTTLE	LIQUID	20	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12830-864-04	ML - Milliliter	12830-864	63e03d4b-e950-44f7-a936-0e40e6136f00	1	2018-01-12
12830-864-16	ML - Milliliter	12830-864	12c5c59a-9f05-47bc-925f-d6c925c87390	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOPHEDIANOL HYDROCHLORIDE	ACTIVE INGREDIENT	69QQ58998Y	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
DEXBROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	BPA9UT29BS	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
CHLOPHEDIANOL	ACTIVE MOIETY	42C50P12AP	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
DEXBROMPHENIRAMINE	ACTIVE MOIETY	75T64B71RP	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12830-864	CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]	12	Current NDC, Legacy NDC, 3 package rows	20240321_d046f4ba-5753-4ed5-a924-0b66fd116781.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 87 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Supress DX Pediatric Drops	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	ddb95436-7806-4086-af4d-18a6625b5c83	2025-11-20	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ct	MENTHOL	Riclan S.A.	0f0260df-89ac-4b83-afea-3aff56ff1b43	2025-11-18	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ct	MENTHOL	Riclan S.A.	16f6d531-9298-4172-8d08-ecd87d6add76	2025-11-18	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	a6f750c8-8738-4965-a3ad-612c24611056	2025-11-18	Warnings	Exact identifier application number: M012
YINCHIAO	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	09ba45f6-03e1-46b9-83ab-a618b2626716	2025-11-18	Warnings	Exact identifier application number: M012
GANMAOLING	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	c757a03e-59ea-469c-970d-4bc62e73f36f	2025-11-18	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	e1d545dc-9222-4d61-964d-1c781215d7d2	2025-11-18	Warnings	Exact identifier application number: M012
Goodnow cold flu day relief cold flu night relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Gobrands, Inc	7590d0c6-121e-4016-b6bb-534c5d0a7970	2025-11-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	R J General Corporation	d786ae07-ce57-44c7-9ba5-f4c87df115de	2025-11-17	Warnings	Exact identifier application number: M012
Benadryl Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	R J General Corporation	c46c01c0-29f4-400c-bef5-14b3eb944c51	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL COLD AND FLU	ACETAMINPHEN	R J General Corporation	b618877b-9dbc-4ba2-be2c-bf1922c646cc	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL SINUS SEVERE	ACETAMINOPHEN	R J General Corporation	2cbf7954-b28f-4d7b-b142-6c6c5c58b25d	2025-11-17	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	R J General Corporation	8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc	2025-11-17	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	QUALITY CHOICE (Chain Drug Marketing Association)	c0e3c959-bed6-2ce5-e053-2995a90a0be9	2025-11-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	c5ea5a7a-c806-e5e0-e053-2995a90a15e9	2025-11-17	Warnings	Exact identifier application number: M012
Multi-Symptom Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	50f3157b-5788-4b63-835a-e60c8dc33df9	2025-11-17	Warnings	Exact identifier application number: M012
Day and Night Sinus	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	a9d809f5-63a1-4f80-8b4d-33e8e052c7bd	2025-11-15	Warnings	Exact identifier application number: M012
Cold and Flu Day, Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	937b481a-e0b7-4d34-a8a1-0bfb2b867c2b	2025-11-15	Warnings	Exact identifier application number: M012
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	f701a6ae-200d-48dc-94e4-6bd3228f50d4	2025-11-15	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	b1fae7cc-4033-44bc-aa7c-ca3ceea51c7d	2025-11-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69QQ58998Y	CHLOPHEDIANOL HYDROCHLORIDE	511-13-7	CHLOPHEDIANOL HYDROCHLORIDE
BPA9UT29BS	DEXBROMPHENIRAMINE MALEATE	2391-03-9	DEXBROMPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1551286	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral Solution	PSN	d046f4ba-5753-4ed5-a924-0b66fd116781	13
1551286	chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution	SCD	d046f4ba-5753-4ed5-a924-0b66fd116781	13
1551286	chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution	SY	d046f4ba-5753-4ed5-a924-0b66fd116781	13
1551286	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral Solution	PSN	bca1807a-6040-4001-bce4-57c48e647ded	1
1551286	chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution	SCD	bca1807a-6040-4001-bce4-57c48e647ded	1
1551286	chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution	SY	bca1807a-6040-4001-bce4-57c48e647ded	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12830-864-04	12830086404	120 mL in 1 BOTTLE (12830-864-04)	120 ml	2017-10-20	0000-00-00	No	No	Current
12830-864-16	12830086416	473 mL in 1 BOTTLE (12830-864-16)	473 ml	2014-09-15	0000-00-00	No	No	Current
12830-864-20	12830086420	20 mL in 1 BOTTLE (12830-864-20)	20 ml	2014-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlo Hist Oral Solution	R. A. McNeil Company	2025-10-15	HUMAN OTC DRUG LABEL	13
Chlo Hist Oral Solution	A-S Medication Solutions	2019-01-16	HUMAN OTC DRUG LABEL	1