NDC 63654-601-01 - 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
- 63654-601
- Requested NDC
- 63654-601-01
- Package NDCs from labels
- 63654-601-04, 63654-601-50, 63654-601-02, 63654-601-20, 63654-601-01, 63654-601-10
- Manufacturer
- Selder, S.A. de C.V.
- Effective date
- 2024-10-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| XL3FrteactmnphnchlrphnirmnphnylphrinhclSldr | Selder, S.A. de C.V. | 2024-10-24 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63654-601-01 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 63654-601-02 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 63654-601-04 | Cold MedicineXL3 FORTE | 4 in 1 PACKET | TABLET | 4 | 7 | |
| 63654-601-10 | Cold MedicineXL3 FORTE | 1 in 1 BOX | TABLET | 1 | 7 | |
| 63654-601-20 | Cold MedicineXL3 FORTE | 2 in 1 BOX | TABLET | 2 | 7 | |
| 63654-601-50 | Cold MedicineXL3 FORTE | 50 in 1 BOX | TABLET | 50 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63654-601 | COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [SELDER, S.A. DE C.V.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241027_51dd467b-aae8-41fa-e054-00144ff8d46c.zip |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dehydrated Alcohol | ALCOHOL | Avenacy, LLC | 90e92d21-9821-4132-b17d-d98d523f12e8 | 2026-07-31 | Warnings, Adverse reactions | 3K9958V90M |
| Pain Relief Acetaminophen 325 mg | ACETAMINOPHEN | NUVICARE LLC | 49a59b79-b8b4-4bf5-a403-0a14751efc55 | 2026-07-30 | Warnings | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Lifestar Pharma LLC | 1767c4b7-36a0-4e64-9091-2af22161402f | 2026-07-30 | Warnings, Adverse reactions | 04JA59TNSJ |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| WhiskCare 373 | ALCOHOL | Whisk Products, Inc. | 57d5cd5d-8597-ce66-e063-6394a90a0047 | 2026-07-30 | Warnings | 3K9958V90M |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| KinderFarms Childrens Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 4f86419a-b940-a9c6-e063-6394a90a6a2b | 2026-07-30 | Warnings | 362O9ITL9D |
| WhiskCare 373 | ALCOHOL | Whisk Products, Inc. | cce95a6a-1188-4c69-8f20-4a1670c4c09b | 2026-07-30 | Warnings | 3K9958V90M |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Lifestar Pharma LLC | f43e4abd-0083-4fe5-9c27-0ba9245e5138 | 2026-07-30 | Warnings, Adverse reactions | 04JA59TNSJ |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 362O9ITL9D |
| Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio Brulee | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 57bd148e-f9eb-dfb6-e063-6394a90a1e12 | 2026-07-29 | Warnings | 3K9958V90M |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 4c966d73-77c6-4514-954e-57aa06a080c6 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| KinderFarms Infants Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 5468b149-8fac-8d6a-e063-6294a90a8c51 | 2026-07-29 | Warnings | 362O9ITL9D |
| Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber Melon | ALCOHOL | Shenzhen Lantern Scicence Co.,Ltd. | 57cb54f7-07be-524f-e063-6294a90a2c94 | 2026-07-29 | Warnings | 3K9958V90M |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| PERCOCET | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Endo USA, Inc. | 4dd36cf5-8f73-404a-8b1d-3bd53bd90c25 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |