BACZOL COLD MEDICINE
- Product NDC
- 76864-208
- 11-digit product format
- 768640208
- Labeler code
- 76864
- Product ID
- 76864-208_c202046a-554a-d677-e053-2a95a90a7389
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Procaps S.A. de C.V.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-05-25
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 250 mg/5mL; mg/5mL; mg/5mL; mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 76864-208 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 76864-208 | 76864-208-01 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76864-208-01 | 2023-08-28 | C162847 | 48780-1 | f386c649-e5ac-0266-e053-dadaa90a7c1a | BACZOL COLD (Lex) |
| 76864-208-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-e5ac-0266-e053-dadaa90a7c1a | BACZOL COLD (Lex) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76864-208-01 | BACZOL COLD MEDICINE | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | 6 | |
| 76864-208-01 | BACZOL COLD MEDICINE | 1 in 1 CARTON | SYRUP | 1 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76864-208 | BACZOL COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) SYRUP [PROCAPS S.A. DE C.V.] | 6 | Legacy NDC, 2 package rows | 20241228_9d07b895-27ff-48b4-a597-29782a67a201.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1370440 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 9d07b895-27ff-48b4-a597-29782a67a201 | 6 |
| 1370440 | acetaminophen 50 MG/ML / chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 9d07b895-27ff-48b4-a597-29782a67a201 | 6 |
| 1370440 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 per 5 ML Oral Solution | SY | 9d07b895-27ff-48b4-a597-29782a67a201 | 6 |
| 1370440 | APAP 50 MG/ML / Chlorpheniramine Maleate 0.8 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Phenylephrine Hydrochloride 2 MG/ML Oral Solution | SY | 9d07b895-27ff-48b4-a597-29782a67a201 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76864-208-01 | 76864020801 | 1 BOTTLE, PLASTIC in 1 CARTON (76864-208-01) > 120 mL in 1 BOTTLE, PLASTIC | 2020-05-25 | 0000-00-00 | No | No | Current |