Natural Orange Flavor
- Product NDC
- 68163-571
- 11-digit product format
- 681630571
- Labeler code
- 68163
- Product ID
- 68163-571_60366b53-67b0-4db0-9156-402ebcd88ef2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Psyllium husk
- Dosage form
- POWDER
- Route
- ORAL
- Labeler
- Raritan Pharmaceuticals Inc
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-20
- Substance
- PSYLLIUM HUSK
- Active strength
- 3.4 g/12g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68163-571-72 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68163-571-72 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68163-571-72 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68163-571-72 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68163-571-72 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68163-571-72 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68163-571-72 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- Natural Orange Flavor
- Brand name suffix
- Organic Natural Fiber
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PSYLLIUM HUSK | 3.4 g/12g |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-04-08 | c30129ac-4517-48b5-aafd-e65ec54b340e |
| 2025-04-08 | c30129ac-4517-48b5-aafd-e65ec54b340e |
| 2025-01-30 | c30129ac-4517-48b5-aafd-e65ec54b340e |
| 2025-01-30 | c30129ac-4517-48b5-aafd-e65ec54b340e |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68163-571-72 | Natural Orange FlavorOrganic Natural Fiber | 864 g in 1 CANISTER | POWDER | 864 | 6 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | b1d903a5-1d5f-44d4-9939-a4b86e5a620d | 2024-05-23 | Warnings | M007 |
| Senna laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | 30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8 | 2024-05-23 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | MEIJER, INC. | 11fe5bd0-585a-ad8a-e063-6294a90a3ae8 | 2024-05-22 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Sam's West, Inc | b14d2495-1092-4063-869f-73a7e8c28708 | 2024-05-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d | 2024-05-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | c0898583-4bbb-41d5-9e84-00cca823024f | 2024-05-15 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9c986ca8-d540-49c1-b092-94c1bf837c07 | 2024-05-09 | Warnings | M007 |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 381f4179-0c3b-41f8-927c-c88534ebe06d | 2024-05-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | ed20d198-e935-200e-e053-2a95a90a309b | 2024-05-02 | Warnings | M007 |
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Major Pharmaceuticals | 1768b470-2808-fa46-e063-6394a90ac8d9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Stimulant laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9467e1f7-19bb-4fb3-853b-75c4d28bb9a9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | c1e9863a-c229-4694-b450-6b0e0ad37503 | 2024-04-30 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 96c7f8bc-be95-40d1-9977-44b7cc6582df | 2024-04-22 | Warnings | M007 |
| Pedia-Lax | MAGNESIUM HYDROXIDE | C.B. Fleet Company, Inc. | 975f24d8-218c-40f4-84a5-558acf34329d | 2024-04-11 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | H E B | 2f9e2723-53a7-47a8-8c41-87bffc4e50dd | 2024-04-09 | Warnings | M007 |
| Senna | SENNOSIDES | H E B | d047e4e9-b8ac-498e-9fde-8af5d415edaa | 2024-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 5b8bcc6c-de03-4d73-a76f-6f4c371cf250 | 2024-04-09 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | H E B | 1dd2be7e-bdca-4e43-b853-3ed10b636632 | 2024-04-08 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 1f11cf85-b094-4ca4-8b48-2d3a9093304b | 2024-04-04 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 824586 | psyllium 3.4 GM Powder for Oral Suspension | PSN | c30129ac-4517-48b5-aafd-e65ec54b340e | 6 |
| 824586 | psyllium 3400 MG Powder for Oral Suspension | SCD | c30129ac-4517-48b5-aafd-e65ec54b340e | 6 |
| 824586 | psyllium 3.4 GM Powder for Oral Suspension | SY | c30129ac-4517-48b5-aafd-e65ec54b340e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68163-571-72 | 68163057172 | 864 g in 1 CANISTER (68163-571-72) | 864 g | 2019-03-20 | 0000-00-00 | No | No | Current |