Chlo Tuss

Product NDC: 12830-762
11-digit product format: 128300762
Labeler code: 12830
Product ID: 12830-762_413d58e3-7690-f93d-e063-6394a90a2344
Type: HUMAN OTC DRUG
Nonproprietary name: Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: R.A. McNeil Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-10-01
Substance: CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 · 6 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
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	12830-762-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12830-762-16	`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	12830-762-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	12830-762-16	`fb8cb913e6d1…`	`eb8c232b6be0…`

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 Tuss
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg/5mL
DEXBROMPHENIRAMINE MALEATE	1 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69QQ58998Y	Internal UNII lookup
BPA9UT29BS	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441376	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
43610aaa-8b94-40d5-ae09-3d75bd2317c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
12830-762-15	2024-03-19	Chlo Tuss
12830-762-15	2024-03-19	Chlo Tuss
12830-762-16	2024-03-19	Chlo Tuss
12830-762-16	2024-03-19	Chlo Tuss
12830-762-15	2024-01-30	Chlo Tuss
12830-762-15	2024-01-30	Chlo Tuss
12830-762-16	2024-01-30	Chlo Tuss
12830-762-16	2024-01-30	Chlo Tuss
12830-762-15	2022-12-22	Chlo Tuss
12830-762-15	2022-12-22	Chlo Tuss
12830-762-16	2022-12-22	Chlo Tuss
12830-762-16	2022-12-22	Chlo Tuss
12830-762-15	2022-07-29	Chlo Tuss
12830-762-15	2022-07-29	Chlo Tuss
12830-762-16	2022-07-29	Chlo Tuss
12830-762-16	2022-07-29	Chlo Tuss

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12830-762-15	Chlo Tuss	15 mL in 1 BOTTLE	LIQUID	15		9
12830-762-16	Chlo Tuss	473 mL in 1 BOTTLE	LIQUID	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12830-762-16	ML - Milliliter	12830-762	439eb45c-6244-49a3-a05d-4394fe9dcbd4	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlophedianol Hydrochloride	ACTIVE INGREDIENT	69QQ58998Y	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Dexbrompheniramine Maleate	ACTIVE INGREDIENT	BPA9UT29BS	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Chlophedianol	ACTIVE MOIETY	42C50P12AP	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Dexbrompheniramine	ACTIVE MOIETY	75T64B71RP	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12830-762	CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]	8	Current NDC, Legacy NDC, 2 package rows	20240321_43610aaa-8b94-40d5-ae09-3d75bd2317c8.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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	1b591e27-b00b-41c8-9fe9-c633aba09134	2025-08-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	377248b6-d64d-8dff-e063-6394a90a43f6	2025-07-31	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	3771f778-7ac9-7108-e063-6394a90a1105	2025-07-31	Warnings	Exact identifier application number: M012
tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca	2025-07-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Wal-Mart Stores Inc	c38a2783-aed9-466d-8976-59d03a792c04	2025-07-30	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3b15d2ea-f784-275d-e063-6394a90a800c	2025-07-29	Warnings	Exact identifier application number: M012
Respiratory Relief	GUAIFENESIN	Schwabe North America, Inc	f683041a-4ff9-42a5-9047-a9a3140a8758	2025-07-29	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	b87f700e-3414-463c-80d4-c3dbca89a488	2025-07-29	Warnings	Exact identifier application number: M012
Tussin DM	TUSSIN DM	Allegiant Health	7a2f8d48-3123-4c37-b238-bd7cc4242bb7	2025-07-23	Warnings	Exact identifier application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	5fb2438b-8f2d-4af2-9981-42d278d26800	2025-07-23	Warnings	Exact identifier application number: M012
DR. SANA COUGH AND CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	baca0580-4c30-4b94-89fa-a7cf06d4ff25	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D	ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI	Menper Distributors, Inc.	f466c660-69eb-4581-81ff-1499fa421d8b	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D Blister Pack	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI	Menper Distributors, Inc.	0dfcc977-6101-4536-e063-6294a90a7a48	2025-07-22	Warnings	Exact identifier application number: M012
Broncofin	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Menper Distributors, Inc.	fdf67382-1692-485b-92f1-2cbb8be4fb70	2025-07-22	Warnings	Exact identifier application number: M012
Defensol Adult Syrup	GUAIFENESIN, DEXTROMETHORPHAN HBR	Menper Distributors, Inc.	62acff69-8c40-4a0e-8d56-be2cc14e3d45	2025-07-22	Warnings	Exact identifier application number: M012
Cosedal Drops	DEXTROMETHORPHAN HBR, GUAIFENESIN	Menper Distributors, Inc.	1241d249-ea3b-4d2b-87ed-835d6a2d286a	2025-07-22	Warnings	Exact identifier application number: M012
Berro y Cebolla DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Menper Distributors, Inc.	20107bd9-6d84-4ab5-a0d9-966f1f11d919	2025-07-22	Warnings	Exact identifier application number: M012
Defensol-ito	DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE	Menper Distributors, Inc	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Children	GUAIFENESIN, DEXTROMETHORPHAN	MENPER DISTRIBUTORS INC.	896a5443-e3d2-4af7-9e27-f1c1899ce038	2025-07-22	Warnings	Exact identifier application number: M012
Bisolvine Aloe-Miel	DEXTROMETHORPHAN, GUAIFENESIN	MENPER DISTRIBUTORS INC.	34801c79-ce88-492f-808e-b639e8601607	2025-07-22	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
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1441376	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	43610aaa-8b94-40d5-ae09-3d75bd2317c8	9
1441376	chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	43610aaa-8b94-40d5-ae09-3d75bd2317c8	9
1441376	chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution	SY	43610aaa-8b94-40d5-ae09-3d75bd2317c8	9
1441376	chlophedianol HCl 25 MG / dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG per 10 ML Oral Solution	SY	43610aaa-8b94-40d5-ae09-3d75bd2317c8	9
1441376	chlophedianol HCl 6.25 MG / dexbrompheniramine maleate 0.5 MG / pseudoephedrine HCl 15 MG per 2.5 ML Oral Solution	SY	43610aaa-8b94-40d5-ae09-3d75bd2317c8	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12830-762-15	12830076215	15 mL in 1 BOTTLE (12830-762-15)	15 ml	2015-01-09	0000-00-00	No	No	Current
12830-762-16	12830076216	473 mL in 1 BOTTLE (12830-762-16)	473 ml	2013-10-01	0000-00-00	No	No	Current