Home NDC 12830-864 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 71 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Safeway Inc. 4a52c0c2-8659-2819-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Cherry Cough Drops MENTHOL Safeway a733e905-af15-d3ea-e053-2a95a90aa7c3 2025-12-20 Warnings Exact identifier application number: M012 Signature Care Honey Lemon Cough Drops MENTHOL Safeway a742449f-c76b-2b91-e053-2a95a90ae4d2 2025-12-20 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE TopCo 60b876e7-c642-5ce8-e053-2a91aa0abd6e 2025-12-20 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Topco Associates 366cc6b1-beff-29d2-e054-00144ff88e88 2025-12-20 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL TopCo Associates 3fef2117-7311-1e66-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Topco Associates 3ff1bf05-e407-3b67-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL Topco Associates 36727f0c-d6d2-28a3-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL Topco Associates 36824bee-607e-7095-e054-00144ff8d46c 2025-12-20 Warnings Exact identifier application number: M012 Mixed Berry Sore Throat Lozenges BENZOCAINE Topco Associates 7a00c771-9231-e877-e053-2a91aa0ac96e 2025-12-20 Warnings Exact identifier application number: M012 MUCUS RELIEF GUAIFENESIN 400 MG NUVICARE LLC e25b440e-f389-443f-b333-c66ad1747158 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu severe ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL Wal-Mart Stores Inc 9fca25dc-f63e-487a-8b7c-84d65ea51cb5 2025-12-19 Warnings Exact identifier application number: M012 Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Geiss, Destin & Dunn Inc. a7d2eaee-484e-43aa-8ae3-0e050219383f 2025-12-19 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Publix 66d8e5f7-9766-57f3-e053-2991aa0a7e17 2025-12-19 Warnings Exact identifier application number: M012 Honey Lemon Cough Drops MENTHOL Publix 66e89fa3-ee09-1d16-e053-2a91aa0ae17c 2025-12-19 Warnings Exact identifier application number: M012 Poly-Vent DM DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL Poly Pharmaceuticals, Inc. 739329ae-0b62-4eab-a07d-867b5d3d61e0 2025-12-19 Warnings Exact identifier application number: M012 Chest Congestion and Cough Relief DM DEXTROMETHORPHAN HBR, GUAIFENESIN ARMY AND AIR FORCE EXCHANGE SERVICE 89494a7c-cdbf-48f1-aaa9-2e57d4388a68 2025-12-19 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# 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