FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12830-762-151332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12830-762-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage12830-762-15fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage12830-762-16fb8cb913e6d1…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
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/5mL
DEXBROMPHENIRAMINE MALEATE1 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
69QQ58998YInternal UNII lookup
BPA9UT29BSInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1441376Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43610aaa-8b94-40d5-ae09-3d75bd2317c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
12830-762-152024-03-19Chlo Tuss
12830-762-152024-03-19Chlo Tuss
12830-762-162024-03-19Chlo Tuss
12830-762-162024-03-19Chlo Tuss
12830-762-152024-01-30Chlo Tuss
12830-762-152024-01-30Chlo Tuss
12830-762-162024-01-30Chlo Tuss
12830-762-162024-01-30Chlo Tuss
12830-762-152022-12-22Chlo Tuss
12830-762-152022-12-22Chlo Tuss
12830-762-162022-12-22Chlo Tuss
12830-762-162022-12-22Chlo Tuss
12830-762-152022-07-29Chlo Tuss
12830-762-152022-07-29Chlo Tuss
12830-762-162022-07-29Chlo Tuss
12830-762-162022-07-29Chlo Tuss

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12830-762-15Chlo Tuss15 mL in 1 BOTTLELIQUID159
12830-762-16Chlo Tuss473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12830-762-16ML - Milliliter12830-762439eb45c-6244-49a3-a05d-4394fe9dcbd412013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlophedianol HydrochlorideACTIVE INGREDIENT69QQ58998YCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
Dexbrompheniramine MaleateACTIVE INGREDIENTBPA9UT29BSCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
ChlophedianolACTIVE MOIETY42C50P12APCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
DexbrompheniramineACTIVE MOIETY75T64B71RPCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
SorbitolINACTIVE INGREDIENT506T60A25RCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2
WaterINACTIVE INGREDIENT059QF0KO0RCHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12830-762CHLO TUSS (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [R.A. MCNEIL COMPANY]8Current NDC, Legacy NDC, 2 package rows20240321_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 105 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012
Ephedrine SulfateEPHEDRINE SULFATEWalgreen Companydc0072f9-7111-1af0-e053-2a95a90aed562025-09-04WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS Pharmacy, Inc31aa77e0-cfdb-57a8-e063-6394a90af98c2025-09-04WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATECVS Pharmacy, Inc.4bb70a55-de44-3dc1-e054-00144ff8d46c2025-09-04WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de637b1-3402-db86-e063-6294a90ac9812025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCf4a9cfec-0725-8f4a-e053-2995a90a1b4a2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de65c99-6c2d-3650-e063-6394a90aa98c2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEMedical Group Care LLCf4a9d879-4736-4f63-e053-2995a90adeba2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de66240-441c-00ad-e063-6294a90a4a052025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCff99c57a-e06a-69d3-e053-6394a90a67752025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de7ace0-e389-b751-e063-6394a90ab4e92025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441376chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN43610aaa-8b94-40d5-ae09-3d75bd2317c89
1441376chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD43610aaa-8b94-40d5-ae09-3d75bd2317c89
1441376chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY43610aaa-8b94-40d5-ae09-3d75bd2317c89
1441376chlophedianol HCl 25 MG / dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG per 10 ML Oral SolutionSY43610aaa-8b94-40d5-ae09-3d75bd2317c89
1441376chlophedianol HCl 6.25 MG / dexbrompheniramine maleate 0.5 MG / pseudoephedrine HCl 15 MG per 2.5 ML Oral SolutionSY43610aaa-8b94-40d5-ae09-3d75bd2317c89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12830-762-151283007621515 mL in 1 BOTTLE (12830-762-15) 15 ml2015-01-090000-00-00NoNoCurrent
12830-762-1612830076216473 mL in 1 BOTTLE (12830-762-16) 473 ml2013-10-010000-00-00NoNoCurrent