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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CHAIN DRUG MARKETING ASSOCIATION INC | 7d1b3418-85a8-4ca0-bca7-261b2b58032a | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH COLD, FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc. | bfc38500-5706-0d03-e053-2995a90a5c72 | 2026-03-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 2baa0861-dbef-7910-e063-6394a90a117e | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17d5ba7-3302-7931-e053-2a95a90a5a6c | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17b8f17-95f6-37e4-e053-2995a90a411a | 2026-03-26 | Warnings | M012 |
| Ultra concentrated Daytime/ Nighttime Severe Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL | CVS PHARMACY, INC | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23079537-1c06-1373-e063-6394a90a37d2 | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS MENTHOL SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2fa8c-071f-50ab-e063-6394a90a4a4a | 2026-03-26 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 2026-03-26 | Warnings | M012 |
| Vicks childrens Cough Congestion Night | PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 87231460-8b45-b995-e053-2a91aa0a6c43 | 2026-03-26 | Warnings | M012 |
| VICKS CHILDRENS COUGH CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | f1d67797-c806-261d-e053-2a95a90a3c15 | 2026-03-26 | Warnings | M012 |
| childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | 686f43ea-4296-4eee-b762-9a9e68344340 | 2026-03-26 | Warnings | M012 |
| Tussin DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59d3a486-97c2-4e60-90e2-1b5bfa7638c7 | 2026-03-26 | Warnings | M012 |
| flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Meijer Distribution Inc | 1a853e47-21a2-40e1-9e64-290af4843b13 | 2026-03-25 | Warnings | M012 |
| cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | c4dcc427-aeec-4a26-80f3-02a4b227a520 | 2026-03-25 | Warnings | M012 |
| Walgreens Lavender Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a1a00-852d-2756-e063-6394a90a5e29 | 2026-03-25 | Warnings | M012 |
| Walgreens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 2d56ddcd-3cc8-51eb-e063-6394a90ae745 | 2026-03-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TWIN MED LLC | 7b000478-649d-4511-b3e0-eea6995b9784 | 2026-03-25 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f32457-23bf-d8a8-e063-6294a90a1e0d | 2026-03-25 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY SUGAR-FREE | Medical Group Care LLC | f4a9ba87-c2a1-2de0-e053-2a95a90ada4c | 2026-03-25 | 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 |