nasal decongestant
- Product NDC
- 62011-0312
- 11-digit product format
- 620110312
- Labeler code
- 62011
- Product ID
- 62011-0312_f7ac406f-9cc6-4af2-8402-d1b4abaeea07
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Strategic Sourcing Services, LLC (Health Mart)
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 1981-08-25
- Marketing end
- 0000-00-00
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- 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 | 62011-0312 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 62011-0312 | 62011-0312-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 62011-0312 | 62011-0312-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 62011-0312 | 62011-0312-3 | D | Discontinued by firm | 2026-10-05 |
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 | 62011-0312-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62011-0312-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 62011-0312-2 | 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 | 62011-0312-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62011-0312-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 62011-0312-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 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 | 62011-0312-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62011-0312-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62011-0312-1 | 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 | 62011-0312-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62011-0312-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62011-0312-1 | 367a005e9d99… | 383a685ebd0f… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62011-0312-1 | EA - Each | 62011-0312 | 2e7b187b-aafd-4667-a699-9504abb404e7 | 1 | 2017-06-15 |
| 62011-0312-2 | EA - Each | 62011-0312 | 111fc884-d087-4983-b5a7-326a1f86016c | 1 | 2017-11-06 |
| 62011-0312-3 | EA - Each | 62011-0312 | b29fce1b-ca79-495a-9f6c-8d19acccc3ac | 1 | 2017-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62011-0312 | NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC (HEALTH MART)] | 14 | Legacy NDC | 20250411_37d70b85-a519-441d-9b33-784684f55dbc.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62011-0312-1 | 62011031201 | 1 BLISTER PACK in 1 CARTON (62011-0312-1) > 24 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 1981-08-25 | 0000-00-00 | No | No | Current |
| 62011-0312-2 | 62011031202 | 2 BLISTER PACK in 1 CARTON (62011-0312-2) > 24 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 1981-08-25 | 0000-00-00 | No | No | Current |
| 62011-0312-3 | 62011031203 | 4 BLISTER PACK in 1 CARTON (62011-0312-3) > 24 TABLET, FILM COATED in 1 BLISTER PACK | 4 blister pack | 1981-08-25 | 0000-00-00 | No | No | Current |