nasal decongestant
- Product NDC
- 70677-0001
- 11-digit product format
- 706770001
- Labeler code
- 70677
- Product ID
- 70677-0001_a6862b77-0e04-41d5-927f-6b521df4b34c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Strategic Sourcing Services
- Application
- ANDA077442
- Marketing category
- ANDA
- Marketing start
- 2018-04-05
- Marketing end
- 0000-00-00
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 70677-0001 | D | Discontinued by firm | 2026-10-30 | ||
| excluded package | package | 70677-0001 | 70677-0001-1 | D | Discontinued by firm | 2026-10-30 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077442-001 | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | 2005-09-28 | 3a93d1ddd44b… |
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 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70677-0001-1 | nasal decongestant | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | 3 | |
| 70677-0001-1 | nasal decongestant | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-0001-1 | EA - Each | 70677-0001 | 135750cf-b10c-4a21-8222-651f31ca4f2e | 1 | 2018-04-19 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70677-0001 | NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES] | 3 | Legacy NDC, 2 package rows | 20200702_53acd8d9-b9d8-4a38-8597-32043548d832.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 |
|---|---|---|---|---|---|---|
| Pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | Sportpharm LLC | 3b5c81b7-7464-129f-e063-6294a90a48c0 | 2026-02-06 | Warnings | 077442 ANDA077442 |
| Pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | A-S Medication Solutions | 0a2672f0-4e6f-48c9-8571-2d09f06253d7 | 2026-01-29 | Warnings | 077442 ANDA077442 |
| Pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | SAM'S WEST INC | 5a885a10-7751-44f1-b2d9-a918f27604df | 2019-03-29 | Warnings | 077442 ANDA077442 |
| Pseudoephedrine Hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | Chain Drug Marketing Association Inc. | 880d368f-0ce3-4993-b5b1-13bf01310516 | 2019-03-14 | Warnings | 077442 ANDA077442 |
| Pseudoephedrine Hydrochloride | PSEUDOEPHEDRINE HYDROCHLORIDE | Publix Super Markets Inc | 9a6ece8b-7036-4cad-aeb3-993ef4bf614f | 2019-03-14 | Warnings | 077442 ANDA077442 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049154 | pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN | 53acd8d9-b9d8-4a38-8597-32043548d832 | 3 |
| 1049154 | 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD | 53acd8d9-b9d8-4a38-8597-32043548d832 | 3 |
| 1049154 | pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet | SY | 53acd8d9-b9d8-4a38-8597-32043548d832 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70677-0001-1 | 70677000101 | 1 BLISTER PACK in 1 CARTON (70677-0001-1) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2018-04-05 | 0000-00-00 | No | No | Current |