BRONCOCHEM
- Product NDC
- 65131-097
- 11-digit product format
- 651310097
- Labeler code
- 65131
- Product ID
- 65131-097_54539b4d-eb99-4198-8486-bfac15605c04
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE
- Dosage form
- GRANULE, FOR SOLUTION
- Route
- ORAL
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-09-01
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
- Active strength
- 500; 4 mg/13g; mg/13g
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- BRONCOCHEM
- Brand name suffix
- COLD AND FLU TEA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/13g |
| CHLORPHENIRAMINE MALEATE | 4 mg/13g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b7d3f54e-59ef-4b85-a88d-b053058dc1f6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65131-097-12 | BRONCOCHEMCOLD AND FLU TEA | 25 in 1 BOX | GRANULE, FOR SOLUTION | 25 | 11 | |
| 65131-097-52 | BRONCOCHEMCOLD AND FLU TEA | 13 g in 1 PACKAGE | GRANULE, FOR SOLUTION | 13 | 11 | |
| 65131-097-53 | BRONCOCHEMCOLD AND FLU TEA | 6 in 1 BOX | GRANULE, FOR SOLUTION | 6 | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65131-097 | BRONCOCHEM COLD AND FLU TEA (ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE) GRANULE, FOR SOLUTION [LABORATORIO MAGNACHEM INTERNATIONAL SRL] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241215_b7d3f54e-59ef-4b85-a88d-b053058dc1f6.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Simethicone 125MG Gas Relief | SIMETHICONE 125 MG | One2Zee Limited Liability Company | 0df348bf-5a07-4f36-ae70-ca2961a9ce7e | 2026-09-04 | Warnings | M |
| MG DermaSpray 70 | ETHYL ALCOHOL | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 153ed8ff-5632-4f21-84de-2b87ac2bef31 | 2026-08-04 | Warnings | M |
| The Original Mane n Tail Daily Control 2 in 1 Anti Dandruff | PYRITHIONE ZINC | Straight Arrow Products Inc | 68ab55d6-b1a9-46c0-87f0-ec12ad3474bc | 2026-07-09 | Warnings | M |
| Stool Softener Laxative | DOCUSATE SODIUM | ATLANTIC BIOLOGICALS CORP. | c1f588d0-4600-4b97-b2d3-2c08ac351e07 | 2026-06-30 | Warnings | M |
| Docusate Sodium | DOCUSATE SODIUM | PD-Rx Pharmaceuticals, Inc. | 66ca7a94-378b-4476-8060-d9c6f82f57fc | 2026-06-12 | Warnings | M |
| TRIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | HART Health | 3d17aba0-220f-42c4-9e26-5c44857847cd | 2026-05-20 | Warnings, Adverse reactions | M |
| IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Rich | HOMOSALATE, OCTISALATE AND OCTOCRYLENE | LOreal USA Products Inc | 2a44a019-0cc0-439b-aaa5-37582ec5492e | 2026-05-14 | Warnings | M |
| THORACOL | HONEY LEMON COUGH DROPS | HART Health | fee9f594-c619-4d77-bb52-632078e0254e | 2026-04-16 | Warnings | M |
| First Aid and Burn | BENZALKONIUM CHLORIDE, LIDOCAINE | HART Health | 07d447f1-469c-4e34-b807-ede9a449e6ab | 2026-04-15 | Warnings | M |
| HYDROCORTISONE | HYDROCORTISONE CREAM | HART Health | c76fb030-cbb5-4773-aa52-d038cb41d0af | 2026-04-15 | Warnings | M |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Amazon.com Services LLC | 55b0d905-fcc0-40ba-a5dd-331a27a3a209 | 2026-04-07 | Warnings, Adverse reactions | M |
| Docusate Sodium | DOCUSATE SODIUM 100MG | Pharbest Pharmaceuticals, Inc. | 025e03e0-e273-47ed-87f7-98e388abe047 | 2026-03-05 | Warnings | M |
| TEENY TUMMY Gas Relief Drops | SIMETHICONE | ALTANTIC BIOLOGICAS CORP. | 05eadb73-4468-4dae-a67b-133d893feed2 | 2026-02-13 | Warnings | M |
| Relief-PE | ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE | HART Health | 9475fb51-931b-4a89-be6b-62e715d0883e | 2026-01-15 | Warnings | M |
| ASPIRIN | ASPIRIN | HART Health | a1c73edf-861d-478b-9d3c-0eddcc6879cc | 2026-01-14 | Warnings | M |
| HISTAPRIN | DIPHENHYDRAMINE | NorMed | 38786a65-a12b-4479-b63c-b7c15410da04 | 2026-01-14 | Warnings | M |
| Blood Clotting | BENZETHONIUM CHLORIDE AND LIDOCAINE | HART Health | 21668731-8b8a-404f-80ab-962a0a9d5f63 | 2026-01-14 | Warnings | M |
| Bandage | BENZOCAINE AND BENZETHONIUM CHLORIDE | HART Health | 6de57472-6dd0-43b6-8a82-fe459fa99ddb | 2026-01-14 | Warnings | M |
| Sooth-a-Sting | BENZOCAINE, ISOPROPYL ALCOHOL | HART Health | c0e7d661-a9c9-4656-a516-57552848ebe8 | 2026-01-12 | Warnings | M |
| Alcohol | ISOPROPYL ALCOHOL | HART Health | 8d01b10b-7916-420e-9d44-ebd3806fe315 | 2026-01-12 | Warnings | M |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65131-097-12 | 65131009712 | 25 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52) | 25 package | 2017-09-28 | 0000-00-00 | No | No | Current |
| 65131-097-52 | 65131009752 | 13 g in 1 PACKAGE | 13 g | Historical | ||||
| 65131-097-53 | 65131009753 | 6 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52) | 6 package | 2017-09-28 | 0000-00-00 | No | No | Current |