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 |
|---|---|---|---|---|---|---|
| NuValu Epsom Salt | MAGNESIUM SULFATE (HEPTAHYDRATE) | J C SALES | 5a503d8d-7899-4b1e-be6f-8e2a759af265 | 2024-12-04 | Warnings | M007 |
| SENNOSIDES | SENNOSIDES | CVS Pharmacy, Inc. | 6dffc3f5-bae0-c436-e053-2991aa0a0f8b | 2024-12-02 | Warnings | M007 |
| Pure and Gentle | MINERAL OIL | Medline Industries, LP | 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | 2024-11-26 | Warnings | M007 |
| Pure and Gentle Laxative | SODIUM PHOSPHATE | Medline Industries, LP | e3165538-75dd-4f0f-adc8-d4075de10f1e | 2024-11-26 | Warnings | M007 |
| DOCUSATE SODIUM 50 MG | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 7cf1df18-d658-4bff-8a62-365fc5656942 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | c5bdfbfc-d24a-4088-9b60-ecea8120ff43 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b10fdf50-289e-41f3-9b83-a4e4dd892f88 | 2024-11-21 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 85c64624-428d-46fa-8071-f42b8feec049 | 2024-11-21 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0 | 2024-11-21 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Walgreen Co. | d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5 | 2024-11-21 | Warnings | M007 |
| 4718 Enema, Mineral Oil | 4718 ENEMA, MINERAL OIL | Dynarex | 9e51c852-9477-5cf5-e053-2a95a90a97db | 2024-11-20 | Warnings | M007 |
| Relief | SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | Leosons Overseas Corp | 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940 | 2024-11-19 | Warnings | M007 |
| REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Leosons Overseas Corp | 90e7c2b4-35e1-4a27-afea-9257c480e190 | 2024-11-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM 100MG | PuraCap Pharmaceutical LLC | 272c86f1-f229-2ebf-e063-6394a90a3471 | 2024-11-18 | Warnings | M007 |
| Milk of Magnesia Concentrate | MAGNESIUM HYDROXIDE | PAI Holdings, LLC dba PAI Pharma | 2a99a1a8-a830-429f-9cfd-3f29c3d3547c | 2024-11-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 122486e9-74dd-4181-97d1-0b07688280f4 | 2024-11-06 | Warnings | M007 |
| Stratuscare Adult Glycerin | GLYCERIN | Stratus Pharmaceuticals | 3e1935da-5c1f-4942-98dd-320fade82321 | 2024-11-04 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | fdf3c8e1-d554-4cdb-e053-6394a90a542e | 2024-11-01 | 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 |