FDA.reportPublic FDA data

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
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage12830-864-04
excluded packagepackage12830-864-20
excluded packagepackage12830-864-16

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
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/5mL
DEXBROMPHENIRAMINE MALEATE1 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1551286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d046f4ba-5753-4ed5-a924-0b66fd116781Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
12830-864-042022-12-22Chlo Hist Oral Solution
12830-864-042022-12-22Chlo Hist Oral Solution
12830-864-162022-12-22Chlo Hist Oral Solution
12830-864-162022-12-22Chlo Hist Oral Solution
12830-864-202022-12-22Chlo Hist Oral Solution
12830-864-202022-12-22Chlo Hist Oral Solution
12830-864-042022-07-29Chlo Hist Oral Solution
12830-864-042022-07-29Chlo Hist Oral Solution
12830-864-162022-07-29Chlo Hist Oral Solution
12830-864-162022-07-29Chlo Hist Oral Solution
12830-864-202022-07-29Chlo Hist Oral Solution
12830-864-202022-07-29Chlo Hist Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12830-864-04Chlo Hist120 mL in 1 BOTTLELIQUID12013
12830-864-16Chlo Hist473 mL in 1 BOTTLELIQUID47313
12830-864-20Chlo Hist20 mL in 1 BOTTLELIQUID2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12830-864-04ML - Milliliter12830-86463e03d4b-e950-44f7-a936-0e40e6136f0012018-01-12
12830-864-16ML - Milliliter12830-86412c5c59a-9f05-47bc-925f-d6c925c8739012014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998YCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BSCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
CHLOPHEDIANOLACTIVE MOIETY42C50P12APCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RPCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RCHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12830-864CHLO HIST (CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE) LIQUID [R. A. MCNEIL COMPANY]12Current NDC, Legacy NDC, 3 package rows20240321_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 60 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc60af2f-83cb-99ea-e053-6394a90a0b3b2026-01-08WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c1fae6c7-bbac-1320-e053-2a95a90aac5a2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
application number: M012
VanaCof 2CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATEGM Pharmaceuticals, INC0c7c6756-abb2-c10c-e063-6394a90a98632026-01-08WarningsExact identifier
application number: M012
VANACOF XP Cough / Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGM Pharmaceuticals, INC0b3a8cc1-a49f-e1e5-e063-6394a90a1c062026-01-08WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC868ac65a-63e2-46ac-b87d-66b2890867562026-01-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
application number: M012
Sambrosa NightDOXYLAMINE SUCCINATESambrosa Care, Inc.acdc8740-6231-d1e8-e053-2995a90a3b8d2026-01-07WarningsExact identifier
application number: M012
VAPOREXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDLC Laboratories, Inc.971943b1-4199-4f75-9d2d-61242d346b5f2026-01-07WarningsExact identifier
application number: M012
BACTIMICINA COUGH AND COLDDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDLC Laboratories, Inc.2e612c62-9bbb-45f2-a253-aa2bfaeaac702026-01-07WarningsExact identifier
application number: M012
Earths Care Chest RubCAMPHOR, EUCALYPTUS OI, MENTHOLDLC Laboratories, Inc2424f5d5-1772-96f1-e063-6294a90a89ee2026-01-07WarningsExact identifier
application number: M012
Bactimicina Vapor RubVAPOR RUBDLC Laboratories, Inc.176b617a-faf6-7893-e063-6294a90a046b2026-01-07WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company80b218f7-66bb-4e15-a0dc-ec9b6af1b0562026-01-07WarningsExact identifier
application number: M012
tussin cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation13618054-d0c5-4190-b626-e7e91b8557382026-01-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1551286chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral SolutionPSNd046f4ba-5753-4ed5-a924-0b66fd11678113
1551286chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral SolutionSCDd046f4ba-5753-4ed5-a924-0b66fd11678113
1551286chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral SolutionSYd046f4ba-5753-4ed5-a924-0b66fd11678113
1551286chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral SolutionPSNbca1807a-6040-4001-bce4-57c48e647ded1
1551286chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral SolutionSCDbca1807a-6040-4001-bce4-57c48e647ded1
1551286chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral SolutionSYbca1807a-6040-4001-bce4-57c48e647ded1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12830-864-0412830086404120 mL in 1 BOTTLE (12830-864-04) 120 ml2017-10-200000-00-00NoNoCurrent
12830-864-1612830086416473 mL in 1 BOTTLE (12830-864-16) 473 ml2014-09-150000-00-00NoNoCurrent
12830-864-201283008642020 mL in 1 BOTTLE (12830-864-20) 20 ml2014-09-150000-00-00NoNoCurrent