NDC 76095-010-01 - Cold Medicine XL3 FORTE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 76095-010
- Requested NDC
- 76095-010-01
- Package NDCs from labels
- 76095-010-04, 76095-010-50, 76095-010-02, 76095-010-20, 76095-010-01, 76095-010-10
- Manufacturer
- MIDWAY IMPORTING INC. | Selder, S.A. de C.V.
- Effective date
- 2024-10-17
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| XL3FrteactmnphnchlrphnirmnphnylphrinhclMdway | MIDWAY IMPORTING INC. | Selder, S.A. de C.V. | 2024-10-17 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76095-010-01 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 76095-010-02 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 76095-010-04 | Cold MedicineXL3 FORTE | 4 in 1 PACKET | TABLET | 4 | 7 | |
| 76095-010-10 | Cold MedicineXL3 FORTE | 1 in 1 BOX | TABLET | 1 | 7 | |
| 76095-010-20 | Cold MedicineXL3 FORTE | 2 in 1 BOX | TABLET | 2 | 7 | |
| 76095-010-50 | Cold MedicineXL3 FORTE | 50 in 1 BOX | TABLET | 50 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76095-010 | COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241027_58252f15-485c-3061-e053-2a91aa0a2320.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 |
|---|---|---|---|---|---|---|
| Cold and Flu Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 2026-04-27 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kroger | 49a7cd2a-8c0e-2196-e063-6294a90a134a | 2026-04-27 | Warnings | M012 04JA59TNSJ |
| Guaifenesin,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 2026-04-27 | Warnings | M012 362O9ITL9D |
| Acetaminophen , Aspirin and Caffeine | ACETAMINOPHEN , ASPIRIN AND CAFFEINE | Softgel Healthcare Pvt Ltd | 4543e156-1deb-666e-e063-6394a90a719c | 2026-04-27 | Warnings | 362O9ITL9D |
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 45478958-ad86-4d87-e063-6394a90a3c45 | 2026-04-27 | Warnings | 362O9ITL9D |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN | Softgel Healthcare Pvt Ltd | 353ef34f-760d-ae92-e063-6294a90a5b4a | 2026-04-27 | Warnings | M012 362O9ITL9D |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0203d919-dc1f-cca0-e063-6394a90aa1aa | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 507214ad-1e06-fe21-e063-6294a90a59cd | 2026-04-27 | Warnings | M012 04JA59TNSJ V1Q0O9OJ9Z 362O9ITL9D |
| oxycodone hydrochloride and acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | FH2 Pharma LLC | 96b0067e-aabe-df4f-e053-2995a90a4a86 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50738a43-7299-270c-e063-6294a90af2cc | 2026-04-27 | Warnings | M012 |
| Scriptsusa Hand Sanitizer | ALCOHOL | Energized Solution Corp | 4f97edd9-717a-315b-e063-6394a90aade7 | 2026-04-27 | Warnings | 3K9958V90M |
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | Cardinal Health 107, LLC | ab70f3dc-708e-4455-99ff-a2b9fe2d71a3 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Alcohol wet wipes | ALCOHOL WET WIPES | Shandong Aishule Hygiene Products Co., Ltd | f79dbac0-cec0-46bc-e053-6294a90a2b13 | 2026-04-25 | Warnings | 3K9958V90M |
| Wet wipes | WET WIPES | JINGXIN GROUP (M) SDN BHD | 395225b1-486b-1867-e063-6394a90a1865 | 2026-04-25 | Warnings | 3K9958V90M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.