Cough and Cold
- Product NDC
- 63654-800
- 11-digit product format
- 636540800
- Labeler code
- 63654
- Product ID
- 63654-800_24b2193a-79ff-3792-e063-6394a90ad104
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Selder, S.A. de C.V.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-11-15
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 250; 5; 2; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 package | package | 63654-800 | 63654-800-20 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
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
- Cough and Cold
- Brand name suffix
- XL3 Xtra
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 250 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1193292 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| da5b31dd-becd-471a-9392-d0ee4b8f9539 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63654-800-06 | Cough and ColdXL3 Xtra | 6 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 6 | 6 | |
| 63654-800-12 | Cough and ColdXL3 Xtra | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 6 | |
| 63654-800-20 | Cough and ColdXL3 Xtra | 20 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 20 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63654-800 | COUGH AND COLD XL3 XTRA (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241027_da5b31dd-becd-471a-9392-d0ee4b8f9539.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 |
|---|---|---|---|---|---|---|
| Tukol Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 27ab3d86-e960-4d83-aad1-d50d2c8e02a9 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lavender | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 2472ce85-c701-4fcd-e063-6394a90a2765 | 2024-10-14 | Warnings | M012 |
| HealthWise Chest Rub Lemon | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | 24740d5a-aba1-0bd4-e063-6394a90ab2ca | 2024-10-14 | Warnings | M012 |
| Childrens Plus Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ea059b56-dc9a-4a6b-8c16-5dfcdaf4cd43 | 2024-10-14 | Warnings | M012 |
| Theraflu Severe Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN | Haleon US Holdings LLC | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 2024-10-14 | Warnings | M012 |
| Cough Relief Adult | DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f5c57b32-69cb-469e-ad2d-64c00b5e66dc | 2024-10-14 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Publix Super Markets Inc | 94c21df5-c631-4748-a833-288b2298055c | 2024-10-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 8eab9d79-69c1-44b8-9145-a7ebd887d54d | 2024-10-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | e4963eec-fb4a-425c-be19-f514b4f10a7f | 2024-10-11 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 1b4e87f8-3f9e-4865-9128-527d2d621593 | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 2024-10-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3170354a-4752-49a0-97ed-3d9db266a059 | 2024-10-11 | Warnings | M012 |
| Tukol Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 235a6d2b-7302-410c-be35-4d5ff7bbdfce | 2024-10-11 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 6c7b0ea6-bff9-4fd2-9e00-64015c326ee8 | 2024-10-11 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b | 2024-10-11 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d5b4ef6-4eb8-41f6-e053-2a95a90a1350 | 2024-10-10 | Warnings | M012 |
| Tukol Sugar Free Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Genomma Lab USA | 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho CF CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06e96e0c-f21f-e706-e063-6294a90a0780 | 2024-10-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1193292 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 6 |
| 1193292 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 6 |
| 1193292 | APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63654-800-06 | 63654080006 | 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06) | 2018-10-15 | 0000-00-00 | No | No | Current |
| 63654-800-12 | 63654080012 | 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-12) | 2014-08-22 | 0000-00-00 | No | No | Current |
| 63654-800-20 | 63654080020 | 20 in 1 BLISTER PACK | Historical |