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 81 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	bd97e91f-1ae1-379c-e053-2995a90acfdd	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a6a2dd4a-a3c8-2dfa-e053-2995a90ada86	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	bd49121c-7cba-c51f-e053-2995a90a921e	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	a6b8dc25-0fb9-1823-e053-2a95a90adf93	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c2232241-6e57-1427-e053-2995a90a488a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dec468-fbb2-3489-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	d7711cd6-5058-548d-e053-2a95a90ac54d	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	a2f0285b-8550-fd26-e053-2995a90ab615	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	f6c73f61-f4fc-377f-e053-6294a90a3797	2025-12-04	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Bayer Healthcare LLC.	a32e2a5e-9aa0-4e7c-e053-2995a90a3190	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e2877488-3539-cba2-e053-2995a90a6005	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	14951faa-9476-6f29-e063-6394a90a14c7	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION	Bayer HealthCare LLC.	0c120569-622d-3a23-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChews	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	149330be-24bd-b4a4-e063-6394a90a9007	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN	Bayer HealthCare LLC.	5278a128-41ec-4494-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	53188c41-3f13-311b-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	75894849-a0ba-57be-e053-2a91aa0a049a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	531ab703-179a-70ad-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	7588ea67-68a9-4dc0-e053-2991aa0aa471	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Cough	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	75862805-2cfe-fb45-e053-2991aa0a1403	2025-12-04	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