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 |
|---|---|---|---|---|---|---|
| Bisacodyl | BISACODYL SUPPOSITORIES | Oncor Pharmaceuticals | 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c | 2025-01-24 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NuCare Pharmaceuticals, Inc. | 2c65319f-6cf5-aa90-e063-6394a90ad662 | 2025-01-23 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health (Leader) 70000 | cde87f95-73c0-46f5-9349-37e04096048c | 2025-01-22 | Warnings | M007 |
| Senna-Tabs | SENNA 8.6MG | Ulai Health LLC | 485129a0-8340-4f61-be51-5abff5032b8d | 2025-01-20 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Topco Associates, LLC | 0609468d-ee66-49af-be40-e51965b88f6f | 2025-01-20 | Warnings | M007 |
| Soluble Fiber | METHYLCELLULOSE | United Natural Foods, Inc. dba UNFI | 6decd5ef-e8e1-44ae-8465-6266cf18e81e | 2025-01-20 | Warnings | M007 |
| Perdiem | SENNOSIDES, STIMULANT LAXATIVE | Haleon US Holdings LLC | 6b256c8f-3953-4c69-9a16-ffa0511bdbcd | 2025-01-16 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | Everpharm LLC | 0ea9f2b5-4533-4b71-b019-10ecb3c06459 | 2025-01-16 | Warnings | M007 |
| Anecream 5 | LIDOCAINE 5% | Focus Health Group | 1810edc3-093e-402f-bcb0-9c731da283a7 | 2025-01-15 | Warnings | M007 |
| Senna | SENNOSIDES | Reliable 1 Laboratories LLC | ae46a611-20f2-74c8-e053-2995a90a32ce | 2025-01-15 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Reliable-1 Laboratories LLC | a97a1829-f62f-2014-e053-2a95a90a8cc5 | 2025-01-15 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 4d678da0-9ada-4d00-9db9-33b45c776107 | 2025-01-15 | Warnings | M007 |
| Goodsense Fiber laxative 147 | CALCIUM POLYCARBOPHIL | GoodSense | 17f5570b-be85-9dce-e063-6294a90abeaf | 2025-01-14 | Warnings | M007 |
| Sunmark Mineral Oil Laxative | MINERAL OIL | Strategic Sourcing Services | c54f7df2-3845-425f-b13e-3dc000123f3c | 2025-01-14 | Warnings | M007 |
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Ulai Health LLC | c0e27b02-8ef2-4239-8f8c-790f7d978dc0 | 2025-01-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Major Pharmaceuticals | 1541ff5b-11f8-444b-a2a0-8e3086ae650a | 2025-01-10 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | AvPAK | f31a4349-7826-45c0-9388-6b938d167b7a | 2025-01-09 | Warnings | M007 |
| Docusate sodium | DOCUSATE SODIUM | APNAR PHARMA LP | 05b0732b-012f-78ee-e063-6294a90a839a | 2025-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Saline Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | McKesson | e5fdfcfd-5340-4929-9f68-2696110cca8e | 2025-01-07 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. | ee06868b-f741-8da2-e053-2a95a90a9772 | 2025-01-02 | 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 |