Sunmark Cold and Allergy
- Product NDC
- 49348-777
- 11-digit product format
- 493480777
- Labeler code
- 49348
- Product ID
- 49348-777_4fb1391c-7232-4f1c-91b7-b58bc2c78418
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- phenylephrine hcl, brompheniramine maleate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2006-09-11
- Marketing end
- 0000-00-00
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
- Active strength
- 5 mg/10mL; mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 49348-777 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 49348-777 | 49348-777-34 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 49348-777 | 49348-777-37 | D | Discontinued by firm | 2026-10-12 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49348-777-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49348-777-37 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49348-777-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49348-777-37 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49348-777-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49348-777-37 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49348-777-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49348-777-37 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49348-777-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49348-777-37 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49348-777-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49348-777-37 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49348-777-34 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49348-777-37 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49348-777-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49348-777-37 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49348-777-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49348-777-37 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49348-777-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49348-777-37 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49348-777-34 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49348-777-37 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49348-777-34 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49348-777-37 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-777-34 | ML - Milliliter | 49348-777 | 57fe7135-bb10-4b8f-9e49-6e7b9f065c38 | 1 | 2012-07-24 |
| 49348-777-37 | ML - Milliliter | 49348-777 | e9652af1-683f-4495-9c9f-3b3cc638c47c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | IXA7C9ZN03 | SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON] | 1 | |
| BROMPHENIRAMINE | ACTIVE MOIETY | H57G17P2FN | SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | SUNMARK COLD AND ALLERGY CHILDRENS (PHENYLEPHRINE HCL, BROMPHENIRAMINE MALEATE) LIQUID [MCKESSON] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | e7a01146-6183-4dde-8acd-5a3c95dc555d | 1 |
| 1053258 | brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | e7a01146-6183-4dde-8acd-5a3c95dc555d | 1 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Elixir | SY | e7a01146-6183-4dde-8acd-5a3c95dc555d | 1 |
| 1053258 | brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | e7a01146-6183-4dde-8acd-5a3c95dc555d | 1 |
| 1053258 | brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | e7a01146-6183-4dde-8acd-5a3c95dc555d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49348-777-34 | 49348077734 | 1 BOTTLE in 1 CARTON (49348-777-34) > 118 mL in 1 BOTTLE | 1 bottle | 2006-09-11 | 0000-00-00 | No | No | Current |