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 |
|---|---|---|---|---|---|---|
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 396903dc-ae2d-4bf4-b1fd-0017b84abef9 | 2024-02-28 | Warnings | M |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 44730cbd-5b98-49bd-b3b8-6fecb0ccd153 | 2024-02-28 | Warnings | M |
| HYDROCORTISONE | HYDROCORTISONE ACETATE | HART Health | 779f945f-ab69-40de-8d86-ab76debc5c7c | 2024-02-16 | Warnings | M |
| First Aid and Burn | BENZALKONIUM CHLORIDE, LIDOCAINE | HART Health | f5746bba-9d7f-4691-b466-14985473bf14 | 2024-02-16 | Warnings | M |
| IBUPROFEN | IBUPROFEN | HART Health | 1c1374e1-890f-48ab-8f93-e84da9d5bf84 | 2024-01-25 | Warnings | M |
| Hand Sanitizer | ANTISEPTIC GEL | HART Health | f07daf29-d0db-4cf8-8baf-d175c2b2ef50 | 2024-01-25 | Warnings | M |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | HART Health | 0346a322-8f6e-405a-8d17-8bc6ce5105a3 | 2024-01-24 | Warnings | M |
| Alcohol | ISOPROPYL ALCOHOL | NorMed | 441b915a-287f-4734-b4d9-730b3d95e04c | 2024-01-24 | Warnings | M |
| Sooth-a-Sting | BENZOCAINE | HART Health | bd7229b6-813a-4149-bfe2-fe682f270ff4 | 2024-01-18 | Warnings | M |
| First Aid | BENZALKONIUM CHLORIDE, BENZOCAINE | HART Health | a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a | 2024-01-18 | Warnings | M |
| TRIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | HART Health | d8f175f9-f526-4c73-a171-49309ca16cb0 | 2024-01-18 | Warnings, Adverse reactions | 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 |